FDA Calendar

Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.

Exact Dates

Estimated Dates

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APREAprea Therapeutics Inc
APR-1051
Next Generation WEE1 Kinase Inhibitor
06/21/2024
8:40 AM
Provided Update

Aprea Therapeutics, Inc. announced that it will host a virtual KOL event to discuss APR-1051, a highly selective and potentially best-in-class oral WEE1 inhibitor, on Monday, June 24, 2024 at 9:00 AM ET.

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BMYBMYMPBristol-Myers Squibb Company
Opdivo (nivolumab)
Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
European Medicines Agency (EMA)06/21/2024
7:05 AM
Regulatory Update

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study.

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OCGNOcugen Inc
OCU410ST
For Stargardt Disease
06/21/2024
7:03 AM
Provided Update

Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial recently convened and approved to proceed with dosing the high dose of OCU410ST in the dose-escalation phase of the study.

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NMTCNeuroOne Medical Technologies Corp
ICD-10
For sEEG RF Ablation
FDA Approved06/20/2024
6:55 AM
FDA Approval

NeuroOne Medical Technologies Corporation announced that the Centers for Medicare and Medicaid Services (CMS) has approved and granted a new ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) code for the OneRF™ Ablation procedure.

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SRPTSarepta Therapeutics Inc
ELEVIDYS (delandistrogene moxeparvovec-rokl)
Designed to address the underlying cause of Duchenne muscular dystrophy through the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.
FDA Approved06/20/2024
6:35 AM
FDA Approval

Sarepta Therapeutics, Inc. announced U.S. Food and Drug Administration (FDA) approval of an expansion to the labeled indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age.

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ANKTIVA
For Bacillus Calmette-Guérin
06/20/2024
6:27 AM
Provided Update

ImmunityBio, Inc. announced the initial treatment of multiple patients in the United States to receive therapy with ANKTIVA® (nogapendekin alfa inbakicept-pmln), ImmunityBio's recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

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MBOTMicrobot Medical Inc
LIBERTY® Robotic Surgical System
Device
06/20/2024
8:57 AM
Provided Update

Microbot Medical Inc. announced its agreement with Brigham and Women's Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System, as part of its Investigational Device Exemption ("IDE") application.

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KYV-101
In Patients With Progressive Multiple Sclerosis
Investigational New Drug (IND)06/20/2024
8:55 AM
FDA Clearance

Kyverna Therapeutics, Inc. announced that the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its autologous, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of stiff-person syndrome (SPS) in Kyverna's trial, named KYSA-8.

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GILDGilead Sciences Inc
Lenacapavir
For the treatment of HIV infection
Phase 306/20/2024
8:54 AM
Top-line results

Gilead Sciences, Inc announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.

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CLPTClearPoint Neuro Inc
ClearPoint Neuro Navigation software.
Software Version 2.1
06/20/2024
8:49 AM
Provided Update

ClearPoint Neuro, congratulates its partner Aspen Neuroscience, Inc. on use of the ClearPoint Neuro Navigation System to transplant dopaminergic neuron precursor cells (DANPCs) for all enrolled patients with Parkinson's Disease (PD) in its recently launched ASPIRO Phase 1/2a clinical trial.

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ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
Phase 306/20/2024
8:45 AM
Publication

Adial Pharmaceuticals, Inc. announced the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, "Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes." The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company's lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants.

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ALLOAllogene Therapeutics Inc
Cemacabtagene Ansegedleucel
For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Biologics License Applications (BLA)06/20/2024
8:41 AM
Regulatory Update

Allogene Therapeutics Inc announced that BLA Submission Anticipated in 2027

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ALLOAllogene Therapeutics Inc
Cemacabtagene Ansegedleucel
For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Phase 206/20/2024
8:38 AM
Provided Update

Allogene Therapeutics Inc announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy.

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ALTO-101
For Schizophrenia
Phase 206/20/2024
8:34 AM
Study Initiation

Alto Neuroscience, Inc announced the initiation of a Phase 2 double-blind, placebo-controlled study of its transdermal formulation of ALTO-101, a novel PDE4 inhibitor in development for the treatment of cognitive impairment associated with schizophrenia (CIAS).

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TNXPTonix Pharmaceuticals Holding Corp
Tonmya
For the management of fibromyalgia.
New Drug Application (NDA)06/20/2024
8:32 AM
IND Filing

Tonix Pharmaceuticals announced that On track to submit NDA to the FDA in the second half of 2024

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TNXPTonix Pharmaceuticals Holding Corp
Tonmya
For the management of fibromyalgia.
New Drug Application (NDA)06/20/2024
8:28 AM
Regulatory Update

Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for the management of fibromyalgia.

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TPSTTempest Therapeutics, Inc.
TPST-1120
First-Line Regimen for Hepatocellular Carcinoma
Phase 1b/206/20/2024
8:24 AM
Positive Data

Tempest Therapeutics, Inc. announced new positive data from the ongoing global randomized Phase 1b/2 clinical study in which amezalpat2 (TPST-1120), Tempest's PPAR⍺ antagonist, delivered a six-month improvement in median overall survival ("OS") advantage when combined with atezolizumab and bevacizumab in a comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma ("HCC").

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KRBPKiromic BioPharma Inc
Deltacel (KB-GDT-01)
For Non-Small Cell Lung Cancer
Phase 106/20/2024
8:23 AM
Results

Kiromic BioPharma, Inc reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial.

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JNJJohnson & Johnson
Guselkumab
For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Phase 306/20/2024
8:21 AM
Top-line results

Johnson & Johnson announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1

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JAZZJazz Pharmaceuticals PLC
Suvecaltamide
For the potential treatment of moderate to severe essential tremor
Phase 2b06/20/2024
8:15 AM
Top-line results

Jazz Pharmaceuticals plc announced top-line results from the Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET).

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SLNSLNCFSilence Therapeutics PLC
SLN360
Reducing cardiovascular risk in people born with high levels of lipoprotein(a)
Phase 206/20/2024
8:09 AM
Top-line data

Silence Therapeutics plc, announced positive topline 48-week data from the ALPACAR-360 phase 2 study of zerlasiran (SLN360) in 178 subjects with baseline lipoprotein(a), or Lp(a), levels at or over 125 nmol/L at high risk of atherosclerotic cardiovascular disease (ASCVD) events. Zerlasiran is a siRNA (short interfering RNA) designed to lower the body's production of Lp(a), a key genetic risk factor for cardiovascular disease affecting up to 20% of the world's population.

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PTNPalatin Technologies Inc
bremelanotide
For the Treatment of Obesity
Phase 306/20/2024
8:05 AM
Provided Update

Palatin Technologies, Inc. announced that Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025

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PTNPalatin Technologies Inc
bremelanotide
For the Treatment of Obesity
Phase 206/20/2024
8:04 AM
Study Initiation

Palatin Technologies, Inc. announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.

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ONCYOncolytics Biotech Inc
atezolizumab (Tecentriq)
Early-stage breast cancer
06/20/2024
8:02 AM
Dose Update

Oncolytics Biotech® Inc. announced the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients.

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SABSSAB Biotherapeutics
SAB BIO
For Type 1 Diabetes Therapies
06/20/2024
7:59 AM
Provided Update

SAB Biotherapeutics announced its new name, SAB BIO, and visual identity to more closely align with its mission to treat and prevent immune and autoimmune disorders with the use of its unique immunotherapy platform.

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ATAIatai Life Sciences N.V.
ELE-101
Treatment of mental health disorders
Phase 1/2a06/20/2024
7:54 AM
Provided Update

atai Life Sciences announced an update on Beckley Psytech's Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study.

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MNMDMind Medicine Inc
MM120
For Generalized Anxiety Disorder
Meeting With FDA06/20/2024
7:53 AM
FDA Meeting

Mind Medicine announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD.

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TRVNTrevena Inc
TRV045
Diabetic neuropathic pain (DNP)
06/20/2024
7:50 AM
Preclinical Data

Trevena, Inc. announced preclinical data from two separate research collaborations

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NMRA-511
For the treatment of agitation associated with dementia due to Alzheimer's disease
Phase 1b06/20/2024
7:45 AM
Study Initiation

Neumora Therapeutics, Inc announced the initiation of a Phase 1b study evaluating NMRA-511 for the treatment of agitation associated with dementia due to Alzheimer's disease (AD). NMRA-511 is an oral, highly potent and selective antagonist of the vasopressin 1a receptor (V1aR) and is highly brain penetrant. Modulation of the V1aR is known to play a role in the regulation of aggression, stress and anxiety responses.

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OCGNOcugen Inc
OCU400 (AAV5-hNR2E3)
Retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).
Phase 306/20/2024
7:43 AM
Dose Update

Ocugen, Inc announced that the first patient has been dosed in its Phase 3 liMeliGhT clinical trial for OCU400—a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).

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NNVCNanoviricides Inc
NV-387
For MPox and Smallpox virus infections
Phase 206/20/2024
7:41 AM
Provided Update

NanoViricides, reports that the ultra-broad-spectrum antiviral NV-387, a clinical Phase II stage drug candidate, was found to be effective in protecting lungs from damage in a lethally infected Influenza A H3N2 mouse model.Inc

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PTCTPTC Therapeutics Inc
PTC518
Huntington's Disease
Phase 206/20/2024
7:40 AM
Interim Results

PTC Therapeutics, Inc shared interim results from the Phase 2 PIVOT-HD study of PTC518 in Huntington's disease (HD) patients. At Month 12, PTC518 treatment resulted in dose-dependent lowering of mutant huntingtin (mHTT) protein in the blood and cerebrospinal fluid (CSF) in the interim cohort of patients.

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DXCMDexCom Inc
Dexcom G7
Next-Generation Continuous Glucose Monitoring System (CGM)
06/20/2024
7:38 AM
Provided Update

DexCom, Inc. the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, will showcase its expanding focus on Dexcom CGM use among people with Type 2 diabetes, the launch of the Omnipod 5 Automated Insulin Delivery System with Dexcom G7 and its relentless commitment to innovation at the 84th Scientific Sessions of the American Diabetes Association conference held June 21–24, 2024, in Orlando.

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ABBVAbbVie Inc
SKYRIZI (risankizumab-rzaa) PsA
Active Psoriatic Arthritis
FDA Approved06/18/2024
8:18 AM
FDA Approval

AbbVie announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.3 SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases.

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AKL-T01
For Adults with ADHD Through a Video Game
06/18/2024
8:16 AM
FDA Clearance

Akili, Inc announced U.S. Food and Drug Administration (FDA) clearance of EndeavorOTCⓇ (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD).

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BBIOBridgeBio Pharma Inc
BBP-418
Limb Girdle Muscular Dystrophy Type 2i (LGMD2i)
Phase 306/18/2024
9:59 AM
Interim Analysis

BridgeBio Pharma, Inc. announced it has surpassed its interim analysis enrollment target and expects topline interim data from its Phase 3 registrational study (FORTIFY) in individuals with LGMD2I/R9 in 2025.

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NGN-401
For Rett Syndrome
06/18/2024
9:59 AM
Dose Update

Neurogene Inc announced that the first patient in Cohort 2 received high-dose NGN-401 gene therapy in the Phase 1/2 trial for female pediatric patients with Rett syndrome, and high-dose NGN-401 has been well-tolerated following dosing in May 2024.

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ACADACADIA Pharmaceuticals Inc
Trofinetide
Rett Syndrome
06/18/2024
9:59 AM
Interim Data

Acadia Pharmaceuticals, Inc. announced that interim data from the open-label real-world LOTUS™ study will be presented at the 2024 International Rett Syndrome Foundation (IRSF) Annual Scientific Meeting, being held this week in Westminster, Colorado.

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LEXXLXXLexaria Bioscience Corp
DehydraTECH-GLP-1
Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
06/18/2024
9:40 AM
Provided Update

Lexaria Bioscience Corp. announces it has now hired a contract research organization ("CRO") to oversee execution of the Company's 12-week chronic study GLP-1-H24-4, (the "Study") which will evaluate various DehydraTECH-GLP-1 (glucagon-like peptide) formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.

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RLMDRelmada Therapeutics Inc
REL-1017
For the adjunctive treatment of major depressive disorder (MDD).
06/18/2024
9:40 AM
Publication

Relmada Therapeutics, Inc announced the publication of REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, The Journal of Clinical Psychiatry.

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DAWNDay One Biopharmaceuticals
MTX-13
ADC targeting protein-tyrosine kinase 7 (PTK7)
06/18/2024
9:40 AM
Provided Update

Day One Biopharmaceuticals announced it has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7 (PTK7).

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AEMDAethlon Medical Inc
Hemopurifier
Severe COVID-19
06/18/2024
9:40 AM
Regulatory Update

Aethlon Medical, Inc. announced that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).

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LXRXLexicon Pharmaceuticals Inc
sotagliflozin
INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
06/18/2024
9:40 AM
Publication

Lexicon Pharmaceuticals, Inc. announced that the peer-reviewed Journal of the American College of Cardiology: Heart Failure has published a research paper concluding that INPEFA® (sotagliflozin) is cost-effective for people with diabetes and recent worsening heart failure using commonly accepted willingness-to-pay thresholds.

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ANNXAnnexon Inc
ANX005
Huntington’s Disease (HD)
Phase 306/18/2024
9:20 AM
Presentation

Annexon, Inc. announced the Company will have several presentations on the Company's ANX005 Guillain-Barré Syndrome (GBS) program at the 2024 Peripheral Nerve Society (PNS) Annual Meeting being held June 22-25, 2024 at the Palais des congrès de Montréal in Montréal, Canada.

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ASMBAssembly Biosciences Inc
ABI-4334
For the Treatment of Chronic Hepatitis B Virus Infection
Phase 1b06/18/2024
9:20 AM
Dose Update

Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection.

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FDMT4D Molecular Therapeutics Inc
4D-150
Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
06/18/2024
9:20 AM
Interim Analysis

4D Molecular Therapeutics announced that the Company will present the initial interim 24-week landmark analysis from the Population Extension cohort of the PRISM Phase 2 Clinical Trial evaluating 4D-150 in a broad wet AMD patient population at the ASRS Annual Scientific Meeting being held in Stockholm, Sweden from July 17-20, 2024.

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FGENFibroGen Inc
FG-3246
In Patients with Metastatic Castration-Resistant Prostate Cancer
06/18/2024
9:20 AM
Provided Update

FibroGen, Inc. announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET.

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TAKTKPHFTakeda Pharmaceutical Co Ltd
HYQVIA
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Phase 306/18/2024
9:20 AM
Data

Takeda announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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DXRDaxor Corp
BVA-100 (Blood Volume Analyzer)
Diagnostic blood test
06/18/2024
9:20 AM
Provided Update

Daxor Corporation announces today it will exhibit at the American Association of Heart Failure Nurses (AAHFN) 20th Annual Meeting from June 20-22nd, 2024 at the Rosen Shingle Creek Resort in Orlando, Florida.

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ERASErasca, Inc
Naporafenib
Pan-RAF inhibitor naporafenib
Phase 306/18/2024
9:20 AM
Provided Update

Erasca, Inc announced the initiation of the global SEACRAFT-2 Phase 3 trial evaluating the pan-RAF inhibitor naporafenib in combination with the MEK inhibitor trametinib (MEKINIST®) in patients with NRAS-mutant (NRASm) melanoma.

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ERASErasca, Inc
Naporafenib
Pan-RAF inhibitor naporafenib
06/18/2024
9:20 AM
Provided Update

Erasca, Inc announced that Randomized Stage 1 readout for naporafenib plus trametinib vs. trametinib monotherapy expected in 2025

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PRQRProQR Therapeutics NV
AX-0810
For cholestatic diseases
06/18/2024
9:20 AM
Presentation

ProQR Therapeutics NV announced presentation will detail AX-0810, the Company's program targeting NTCP for cholestatic diseases, including further assessment in in vivo models of biomarkers for NTCP.

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PRQRProQR Therapeutics NV
Axiomer
Editing Technology Adenosine Deaminase Acting on RNA)
06/18/2024
9:20 AM
Provided Update

ProQR Therapeutics NV announced it will participate in the RNA Editing Summit, June 18-20, 2024, in Boston, Massachusetts.

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BBIOBridgeBio Pharma Inc
LGMD2I/R9
Monogenic autosomal recessive
Phase 306/18/2024
9:19 AM
Interim Data

BridgeBio Pharma, Inc. announced it has surpassed its interim analysis enrollment target and expects topline interim data from its Phase 3 registrational study (FORTIFY) in individuals with LGMD2I/R9 in 2025.

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ITCIIntra-Cellular Therapies Inc
Lumateperone
For the treatment of MDD
06/18/2024
9:18 AM
Top-line Data Due

Intra-Cellular Therapies, announced positive topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.

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SPY001
For the Treatment of Inflammatory Bowel Disease
06/18/2024
8:25 AM
Dose Update

Spyre Therapeutics, Inc. announced that it has initiated dosing of healthy volunteers in its first clinical trial of SPY001, an investigational novel half-life extended anti-α4β7 monoclonal antibody.

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ALTAltimmune Inc
pemvidutide
for the treatment of obesity and MASH
06/18/2024
8:23 AM
Oral presentation

Altimmune, Inc. announced oral presentations on pemvidutide, an investigational GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH, at the American Diabetes Association's (ADA) 84th Scientific Sessions, to be held in Orlando, FL from June 21-24, 2024.

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TSHATaysha Gene Therapies Inc
TSHA-102
Rett Syndrome
Phase 1/206/18/2024
8:21 AM
Clinical Data

Taysha Gene Therapies, Inc. announced positive longer-term clinical data from the ongoing REVEAL Phase 1/2 adolescent and adult trial and initial clinical data from the REVEAL Phase 1/2 pediatric trial evaluating TSHA-102 in Rett syndrome.

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OLPRUVA®
Treatment for Certain Urea Cycle Disorders
06/18/2024
8:19 AM
Provided Update

Orsini Specialty Pharmacy and Zevra Therapeutics, Inc announced that Orsini is now the pharmacy partner for OLPRUVA® (sodium phenylbutyrate) for oral suspension. OLPRUVA® is a prescription medicine used along with certain therapies, including changes in diet, for long-term management of certain adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS)..

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ZNTLZentalis Pharmaceuticals Inc
azenosertib
Wee1 inhibitor.
06/18/2024
8:15 AM
Clinical Hold

Zentalis® Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). This action follows two recent deaths due to presumed sepsis in the DENALI study.

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RGNXRegenxbio Inc
RGX-121
MPS II (Hunter Syndrome)
Biologics License Applications (BLA)06/18/2024
8:13 AM
Regulatory Update

REGENXBIO Inc. announced that Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024

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RGNXRegenxbio Inc
RGX-121
MPS II (Hunter Syndrome)
Biologics License Applications (BLA)06/18/2024
8:11 AM
FDA Meeting

REGENXBIO Inc announced it completed a successful Pre-Biologics License Application (BLA) meeting for RGX-121 for the treatment Mucopolysaccharidosis Type II (MPS II), where it finalized details of its BLA with the U.S. Food and Drug Administration (FDA).

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CNM-Au8 (HEALEY ALS)
Amyotrophic Lateral Sclerosis
06/18/2024
8:10 AM
Results

Clene Inc , today presented new long-term CNM-Au8 treatment results for survival and neurofilament light (NfL) levels from the HEALEY ALS Platform Trial open label extension (OLE) at the European Network for the Cure of ALS (ENCALS) meeting in Stockholm, Sweden.

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IMCRImmunocore Holdings plc
IMC-F106C
Multiple solid tumor types
06/18/2024
8:07 AM
Provided Update

Immunocore Holdings plc announces randomization of the first patient in the PRISM-MEL-301 trial, assessing the efficacy and safety of brenetafusp (IMC-F106C; PRAME-A02), in combination with nivolumab, in first-line advanced or metastatic cutaneous melanoma.

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CMMBChemomab Therapeutics, Ltd.
CCL24
Key driver of the fibrotic and inflammatory disease
06/18/2024
8:05 AM
Publication

Chemomab Therapeutics announced a new scientific publication that further confirms the important role of the soluble protein CCL24 in the pathologies underlying the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new study reinforces the extensive evidence showing the potential of Chemomab's CCL24-neutralizing antibody, CM-101, to interrupt the biological processes driving PSC disease progression and severity.

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KALVKalVista Pharmaceuticals Inc
sebetralstat
Therapy for hereditary angioedema (HAE).
06/18/2024
7:02 AM
Additional data

KalVista intends to present additional data from the KONFIDENT and KONFIDENT-S trials at the 2024 Annual Scientific Conference of the American College of Allergy, Asthma, and Immunology (ACAAI) Conference on October 24-28, 2024, in Boston, Massachusetts.

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KALVKalVista Pharmaceuticals Inc
sebetralstat
Therapy for hereditary angioedema (HAE).
New Drug Application (NDA)06/18/2024
7:02 AM
IND Filing

KalVista Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.

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AZNAZNCFAstraZeneca PLC
capivasertib
In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer
Phase 306/18/2024
6:55 AM
Endpoint Missed

AstraZeneca announced that The CAPItello-290 Phase III trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC) did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).

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RHHBFRHHBYRHHVFRoche Holding AG
VENTANA DP 200
The system is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides to help diagnose patients.
06/18/2024
6:51 AM
FDA Clearance

Roche announced that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food and Drug Administration (FDA).

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MRKMerck & Co Inc
NRG-GY018
Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin)
FDA Approved06/17/2024
6:46 AM
FDA Approval

Merck announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

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Telomir-1
Potential treatment for age-related conditions
06/17/2024
6:41 AM
Provided Update

Telomir Pharmaceuticals, Inc. announced that its scientific advisor, Adam Kaplin, M.D., Ph.D., was invited by InSilicoTrials to speak on its panel discussion on June 17, 2024, at the DIA Global Annual Meeting. Along with his fellow panelists, Dr. Kaplin will discuss case studies based on his experience using generative AI to provide data modeling solutions to reduce the time and cost of therapeutic studies while upholding strict patient safety standards.

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KYV-101
In Patients With Progressive Multiple Sclerosis
06/17/2024
6:40 AM
Publication

Kyverna Therapeutics, Inc. announced the publication in Proceedings of the National Academy of Sciences (PNAS)1 of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in a 69-year-old patient suffering from treatment-refractory stiff-person syndrome (SPS) as part of a named-patient use in Germany for critically ill individuals who fail conventional therapies.

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MRKMerck & Co Inc
CAPVAXIVE
For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
FDA Approved06/17/2024
6:32 AM
FDA Approval

Merck MRK, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine)

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HJLIHancock Jaffe Laboratories Inc
VenoValve
Chronic Venous Insufficiency (CVI)
06/17/2024
6:30 AM
Presentation

enVVeno Medical Corporation announced that The presentation, entitled "The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux," will be made on Friday, June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.

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HJLIHancock Jaffe Laboratories Inc
VenoValve
Chronic Venous Insufficiency (CVI)
06/17/2024
6:29 AM
Interim Data

enVVeno Medical Corporation announced that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL.

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BNTXBioNTech SE
BNT326/YL202
For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer
Phase 106/17/2024
10:59 AM
Clinical Hold

BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer.

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CYTKCytokinetics Inc
Aficamten
Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Phase 106/17/2024
10:57 AM
Dose Update

Cytokinetics, Incorporated announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants.

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ITOSITeos Therapeutics Inc
Lung-301
Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer
Phase 306/17/2024
9:22 AM
Study Initiation

iTeos Therapeutics, Inc. announced that have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC).

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SLSSELLAS Life Sciences Group Inc
galinpepimut-S (GPS)
Targets the WT1 protein, which is present in an array of tumor types.
Phase 306/17/2024
9:18 AM
Positive Opinion

SELLAS Life Sciences Group, Inc. announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC).

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EVX-01
Metastatic Melanoma
Phase 106/17/2024
8:57 AM
Data Publication

Evaxion Biotech A/S announces publication of data from its Phase 1 dose escalation study of its lead personalized cancer vaccine candidate, EVX-01, for metastatic melanoma.

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AVTEAerovate Therapeutics, Inc.
AV-101
For the Treatment of Pulmonary Arterial Hypertension
Phase 2b06/17/2024
8:49 AM
Top-line results

Aerovate Therapeutics, Inc. announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH).

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FBIOFBIOPMBIOMBRXFortress Biotech Inc
Mustang Bio Inc
Moleculin Biotech Inc
MB-106
Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
Phase 1/206/17/2024
8:47 AM
Updated data

Mustang Bio, Inc. announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T-cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia ("WM"), a rare form of blood cancer.

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APREAprea Therapeutics Inc
APR-1051
Next Generation WEE1 Kinase Inhibitor
Phase 106/17/2024
8:46 AM
Dose Update

Aprea Therapeutics, announced that the first patient has been dosed in the ACESOT-1051 Phase 1 study evaluating daily oral WEE1 inhibitor APR-1051 as monotherapy in advanced solid tumor patients with unmet medical need.

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BMRNBiomarin Pharmaceutical Inc
vosoritide
Children with achondroplasia
Phase 206/17/2024
8:44 AM
Presentation

BioMarin Pharmaceutical Inc announced the presentation of new data from an investigator-led analysis of the Phase 2 111-205 study, which demonstrate that children with achondroplasia treated with VOXZOGO® experienced increases in bone length while maintaining bone strength..

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RLYB212
For the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia
06/17/2024
8:40 AM
Top-line results

Rallybio Corporation reported topline results from an epidemiological analysis of large genomic datasets evaluating the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in diverse ancestries.

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IKTInhibikase Therapeutics Inc
Risvodetinib
Multiple System Atrophy
Phase 206/17/2024
8:38 AM
Enrollment Update

Inhibikase Therapeutics, Inc announced the company has completed enrollment in the Phase 2 ‘201' trial evaluating the safety and tolerability of risvodetinib ("risvo"), a potent selective c-Abl inhibitor, for treatment in untreated Parkinson's patients.

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SLRXSalarius Pharmaceuticals Inc
Seclidemstat
Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas
06/17/2024
8:35 AM
Clinical Data

Salarius Pharmaceuticals, Inc. announced that investigators at the University of Texas MD Anderson Cancer Center's Leukemia department presented clinical data on seclidemstat in patients with MDS and CMML at the 2024 European Hematology Association (EHA) Hybrid Congress. The meeting was held in Madrid and virtually from June 13-16, 2024.

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CanGaroo RM
Next-Generation Biomaterial Envelope Enhanced with Antibiotics
06/17/2024
8:32 AM
FDA Clearance

Elutia Inc. announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient's own tissue.

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TH104
For Chronic Pruritis in Primary Biliary Cholangitis (PBC)
Type C Meeting06/17/2024
8:30 AM
Positive Feedback

Tharimmune, Inc. reports positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) for its Phase 2 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene for moderate-to-severe pruritus or "uncontrolled itching" in primary biliary cholangitis (PBC), a rare form of liver disease with no known cure.

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MIRMMirum Pharmaceuticals Inc
volixibat
For treatment of pruritus in PBC
Phase 2b06/17/2024
8:27 AM
Interim Results

Mirum Pharmaceuticals, Inc announced interim results from two Phase 2b studies evaluating volixibat, an oral ileal bile acid transporter (IBAT) inhibitor in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

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ATNMActinium Pharmaceuticals Inc
Actimab-A + Venetoclax
Relapsed or refractory Acute Myeloid Leukemia (r/r AML)
06/17/2024
8:24 AM
Abstract

Actinium Pharmaceuticals, Inc. announced that an abstract detailing the first ever preclinical data from the combination of menin inhibitors with Actinium's ARC Actimab-A in acute myeloid leukemia (AML) models was presented at the 2024 European Hematology Association (EHA) Congress held June 13 – 16, 2024, in Madrid, Spain.

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ENLVEnlivex Therapeutics Ltd
Allocetra
Sepsis
06/17/2024
8:23 AM
Positive Data

Enlivex Therapeutics Ltd released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of AllocetraTM in patients with end-stage knee osteoarthritis who had been indicated for knee replacement surgery..

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TNXPTonix Pharmaceuticals Holding Corp
Tonmya
For the management of fibromyalgia.
Phase 306/17/2024
8:22 AM
Provided Update

Tonix Pharmaceuticals announced that RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint

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TNXPTonix Pharmaceuticals Holding Corp
Tonmya
For the management of fibromyalgia.
06/17/2024
8:21 AM
Poster Presentation

Tonix Pharmaceuticals Holding Corp. presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company's poster presentation is available under the Scientific Presentations tab of the Tonix

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HUMAHumacyte, Inc.
Human Acellular Vessel
Coronary Artery Bypass Grafting
06/17/2024
8:18 AM
Provided Update

Humacyte, Inc. announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the "acellular tissue engineered vessel" (ATEV).

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GHJNJGuardant Health Inc
Johnson & Johnson
RYBREVANT (amivantamab-vmjw)
Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Biologics License Applications (BLA)06/17/2024
8:16 AM
IND Filing

Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT® (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC).

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NTLAREGNIntellia Therapeutics Inc
Regeneron Pharmaceuticals Inc
NTLA-2001
Transthyretin (ATTR) Amyloidosis
Phase 106/17/2024
8:13 AM
Abstract

Intellia Therapeutics, Inc. announced the acceptance of an abstract featuring redosing data from the Phase 1 study of NTLA-2001 has been selected for an oral presentation at the Peripheral Nerve Society Annual Meeting, taking place June 22 – 25 in Montreal, Canada. NTLA-2001 is an investigational in vivo CRISPR-based gene editing therapy designed to be a single-dose treatment for transthyretin (ATTR) amyloidosis.

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MRNSMarinus Pharmaceuticals Inc
Ganaxolone (RAISE)
Refractory status epilepticus (RSE)
Phase 306/17/2024
7:23 AM
Top-line results

Marinus Pharmaceuticals, Inc announced topline results from the Phase 3 double-blind, randomized, placebo-controlled RAISE trial (NCT04391569) evaluating the safety and efficacy of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE).

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KROSKeros Therapeutics Inc
KER-050
Myelodysplastic Syndromes
Phase 206/17/2024
6:55 AM
Additional data

Keros Therapeutics, Inc. announced that it presented additional data from its two ongoing Phase 2 clinical trials of elritercept (KER-050), one in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes ("MDS") and one in patients with myelofibrosis ("MF"), at the 29th Annual Hybrid Congress of the European Hematology Association ("EHA"), held in person in Madrid, Spain and virtually from June 13 through 16, 2024.

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TAKTKPHFTakeda Pharmaceutical Co Ltd
TAK-935
In Patients with Dravet Syndrome and Lennox-Gastaut Syndrome
Phase 306/17/2024
6:51 AM
Top-line data

Takeda announced topline data from its SKYLINE and SKYWAY studies.

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AZNAZNCFAstraZeneca PLC
Durvalumab
Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
06/17/2024
6:49 AM
Provided Update

AstraZeneca plc’s ancer drug, Imfinzi (durvalumab), in conjunction with standard chemotherapy, has now received endorsement from the U.S. authorities for treating certain severe forms of endometrial cancer.

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ZYMEZymeworks Inc
ZW171
For mesothelin (MSLN)-expressing cancers.
Investigational New Drug (IND)06/17/2024
6:46 AM
FDA Clearance

Zymeworks Inc announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers.

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GIFLFGIFOFGIKLYGRFSGrifols SA
Yimmugo
To treat primary immunodeficiencies (PID).
FDA Approved06/17/2024
6:44 AM
FDA Approval

Grifols announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).

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IPHAIPHYFSNYSNYNFInnate Pharma SA
Sanofi SA
IPH6101/SAR443579
Solid Tumors
Phase 1/206/17/2024
5:03 AM
Efficacy and Safety Data

Innate Pharma SA announced that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR'579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET® platform lead asset, were shared in an oral presentation at the European Hematology Association 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST.

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AZNAZNCFAstraZeneca PLC
CALQUENCE
In patients with treatment-naïve CLL.1
Phase 306/16/2024
4:59 AM
Positive Data

AstraZeneca announced that Positive results from the ECHO Phase III trial showed CALQUENCE®(acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and showed a favorable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

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REGNRegeneron Pharmaceuticals Inc
Linvoseltamab (BCMAxCD3)
Designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
Phase 1/206/16/2024
4:56 AM
Data

Regeneron Pharmaceuticals, Inc. announced that 14-month median follow-up data from the pivotal Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) were shared during an oral presentation at the European Hematology Association (EHA) Congress 2024 and published in the Journal of Clinical Oncology.

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NRIXNurix Therapeutics Inc
NX-5948
Autoimmune Disease
06/16/2024
4:53 AM
Provided Update

Nurix intends to advance NX-5948 into pivotal trial(s) in 2025

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NRIXNurix Therapeutics Inc
NX-5948
Autoimmune Disease
06/16/2024
4:50 AM
Presentation

Nurix Therapeutics, Inc.

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RHHBFRHHBYRHHVFRoche Holding AG
Columvi
Treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
Phase 306/15/2024
4:48 AM
Results

Roche Group announced statistically significant and clinically meaningful results from its Phase III STARGLO study of Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) versus Rituxan® (rituximab) in combination with GemOx (R-GemOx) for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.

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AGIOAgios Pharmaceuticals Inc
Mitapivat
Sickle cell disease
Phase 306/15/2024
4:46 AM
presented results

Agios Pharmaceuticals, today presented detailed results from the global Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia in a plenary session (abstract #S104) at the European Hematology Association 2024 (EHA2024) Hybrid Congress, which is being held June 13-16, 2024, in Madrid, Spain.

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JNJJohnson & Johnson
Nipocalimab
Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Phase 206/15/2024
4:39 AM
Late-Breaking Data

Johnson & Johnson announces patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the Phase 2 DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren's disease (SjD).

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BEIGFBGNEAMGNBeiGene Ltd
Amgen Inc
BLINCYTO (Blinatumomab)
Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
FDA Approved06/14/2024
4:32 AM
FDA Approval

Amgen announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.

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GLPGGLPGFGalapagos NV
GLPG5101
In patients with relapsed/refractory chronic lymphocytic leukemia
Phase 1/206/14/2024
4:28 AM
New Data

Galapagos NV announced that it will present encouraging new data from the ongoing Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) at the annual European Hematology Association (EHA) 2024 Hybrid Congress. Galapagos' product candidate GLPG5101 is produced using the company's innovative, decentralized T-cell manufacturing platform.

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NVAXNovavax Inc
NVX-CoV2705
Updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant.
Emergency Use Authorization (EUA)06/14/2024
4:23 AM
Regulatory Update

Novavax, Inc. announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

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SRNESorrento Therapeutics Inc
SP-102 (SEMDEXA)
Sciatica Pain Management
Phase 306/14/2024
4:21 AM
Published Results

Scilex Holding Company announced the publication of results of the pivotal registration trial of SP-102 (SEMDEXA™) in PAIN, the official journal of the International Association for the Study of Pain, which features original research on the nature, mechanisms and treatment of pain.

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NVDANVIDIA Corp
Nemotron-4 340B
For Inference With TensorRT-LLM
06/14/2024
4:11 AM
Provided Update

NVIDIA today announced Nemotron-4 340B, a family of open models that developers can use to generate synthetic data for training large language models (LLMs) for commercial applications across healthcare, finance, manufacturing, retail and every other industry.

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GLUEMonte Rosa Therapeutics, Inc.
MRT-6160
To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
06/14/2024
8:54 AM
Preclinical Data

Monte Rosa Therapeutics, announced the company will present preclinical data at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress, being held June 12-15 in Vienna, Austria.

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ATNMActinium Pharmaceuticals Inc
Iomab-B
Active Relapsed or Refractory Acute Myeloid Leukemia
Phase 306/14/2024
8:37 AM
Results

Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B were presented at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 – 16, 2024, in Madrid, Spain.

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FBIOFBIOPMBIOMBRXFortress Biotech Inc
Mustang Bio Inc
Moleculin Biotech Inc
MB-106
Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
Phase 1b06/14/2024
8:33 AM
Findings Update

Moleculin Biotech, Inc., reported additional efficacy findings from the Company's ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML).

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JNJJohnson & Johnson
TALVEY
In patients with relapsed or refractory multiple myeloma
Phase 1/206/14/2024
8:30 AM
Data

Johnson & Johnson announced that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with TALVEY® (talquetamab-tgvs) maintained high overall response rates (ORR) and durable responses, irrespective of whether they had received prior T-cell redirection therapy.1

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SNGXSoligenix Inc
SuVax
For the Prevention and Post-Exposure Prophylaxis
06/14/2024
8:29 AM
Data Presentation

Soligenix, Inc. announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™).

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VYD222
For the Prevention of COVID-19
06/14/2024
8:27 AM
Provided Update

Invivyd, Inc. announced that VYD222 (pemivibart), a half-life extended investigational monoclonal antibody (mAb), shows continued in vitro neutralization activity in pseudovirus assays designed to represent the predominant emerging variants of SARS-CoV-2, including the KP.1.1 FLiRT and KP.3 variants.

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SNDXSyndax Pharmaceuticals Inc
Revumenib
Relapsed/Refractory KMT2Ar Acute Leukemia
Phase 1/206/14/2024
8:24 AM
Data

Syndax Pharmaceuticals announced updated data from multiple combination trials of revumenib, the Company's potent, selective, small molecule menin inhibitor, in patients with acute leukemias.

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AUTLAutolus Therapeutics PLC
Obe-cel (AUTO1 - ALLCAR19) ALL
Adult Acute lymphoblastic leukemia (ALL)
06/14/2024
8:22 AM
Abstract

Autolus Therapeutics announces three abstracts to be presented at the European Hematology Association (EHA) Congress, June 13-16, 2024.

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CABACabaletta Bio Inc
CABA-201
CD19 chimeric antigen receptor
Phase 1/206/14/2024
6:44 AM
Data Presentation

Cabaletta Bio, Inc. today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials. These data will be presented today at 8:15 a.m. CEST (2:15 a.m. ET) at a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled "Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease" in Vienna, Austria.

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CABACabaletta Bio Inc
CABA-201
CD19 chimeric antigen receptor
Phase 1/206/14/2024
6:43 AM
Positive Data

Cabaletta Bio, Inc today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials.

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PTGXProtagonist Therapeutics Inc
Rusfertide (PTG-300)
Polycythemia vera (PV)
Phase 206/14/2024
6:40 AM
Presentation

Protagonist Therapeutics, Inc. announced details from two abstracts at the European Hematology Association 2024 Congress, including an oral presentation with long-term follow-up data from the Phase 2 REVIVE study with rusfertide, a mimetic of the natural hormone hepcidin with potential therapeutic value in the treatment of polycythemia vera (PV) and other disease indications.

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STTKShattuck Labs Inc
SL-172154 (AML HR-MDS)
Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS)
06/14/2024
6:39 AM
Provided Update

Shattuck to host conference call and webcast today, June 14, 2024 at 7:30 a.m. ET

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STTKShattuck Labs Inc
SL-172154 (AML HR-MDS)
Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Phase 1b06/14/2024
6:38 AM
Interim Data

Shattuck Labs announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients.

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ZB-106
For the treatment of Sjogren's syndrome.
Phase 106/14/2024
6:35 AM
Data

Zura Bio Limited today shared supportive data from a Phase 1 study evaluating its lead candidate, tibulizumab (ZB-106), for the treatment of Sjogren's syndrome.

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BEIGFBGNEBeiGene Ltd
BRUKINSA® (zanubrutinib)
inhibitor of Bruton's tyrosine kinase
06/14/2024
6:34 AM
Presentation

BeiGene, Ltd. announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) today at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain in an oral session (Abstract S160).

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EDITEditas Medicine Inc
EDIT-301
Transfusion-Dependent Beta Thalassemia
Phase 1/206/14/2024
3:32 AM
Efficacy and Safety Data

Editas Medicine, Inc. announced new safety and efficacy data in 7 patients with transfusion-dependent beta thalassemia (TDT) treated with renizgamglogene autogedtemcel (reni-cel; formerly known as EDIT-301) in the Phase 1/2 EdiTHAL clinical trial. Reni-cel, the first investigational AsCas12a gene-edited cell therapy medicine, is being studied in the EdiTHAL trial as a potential one-time, durable gene editing medicine for people living with TDT.

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BEAMBeam Therapeutics Inc
BEAM-101
Sickle cell diseas
06/14/2024
3:31 AM
Data

Beam Therapeutics Inc. reported data highlighting its optimized, closed and automated manufacturing process for its base-edited CD34+ hematopoietic stem and progenitor cell (HSPC) genetic medicines in a poster presentation at the European Hematology Association (EHA) Hybrid Congress.

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RIGLRigel Pharmaceuticals Inc
REZLIDHIA® (Olutasidenib)
treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
06/14/2024
3:28 AM
Oral presentation

Rigel Pharmaceuticals, Inc announced oral at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain being held June 13-16, 2024, and online.

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RIGLRigel Pharmaceuticals Inc
REZLIDHIA® (Olutasidenib)
treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
06/14/2024
3:29 AM
Poster Presentation

Rigel Pharmaceuticals, Inc. announced four poster presentations at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain being held June 13-16, 2024, and online.

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VRTXVertex Pharmaceuticals Inc
CASGEVY
for the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)
06/14/2024
3:27 AM
Data

Vertex Pharmaceuticals Incorporated announced longer-term data for CASGEVY™ (exagamglogene autotemcel [exa-cel]) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).

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GILDGilead Sciences Inc
Yescarta (Axicabtagene Ciloleucel)
Relapsed or Refractory Follicular Lymphoma (FL)
06/14/2024
3:26 AM
Results

Kite, a Gilead Company announced results from three new analyses for Yescarta® (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid.

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PFEPfizer Inc
Elranatamab
B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
Phase 206/14/2024
3:25 AM
Results

Pfizer Inc announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM).

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ZLABBMYBMYMPZai Lab Ltd
Bristol-Myers Squibb Company
Repotrectinib
NTRK Fusion-Positive Advanced Solid Tumors
FDA Approved06/13/2024
2:03 AM
FDA GRANT

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

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OCULOcular Therapeutix Inc
AXPAXLI
in Diabetic Retinopathy
06/13/2024
2:01 AM
Provided Update

Ocular Therapeutix, Inc. today hosted an Investor Day where it highlighted excellent clinical development progress with AXPAXLI for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and updated its corporate strategy.

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INABIN8bio Inc.
INB-100
Leukemia undergoing haploidentical stem cell transplant (HSCT)
Phase 106/13/2024
1:59 AM
Updated data

IN8bio, Inc. presents updated data from its Phase 1 trial of INB-100 at the European Hematology Association (EHA) 2024 Hybrid Congress.

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URGNUroGen Pharma Ltd
UGN-102
Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Phase 306/13/2024
1:58 AM
Data

UroGen Pharma Ltd announced 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of response (DOR) data by Kaplan-Meier estimate (n=108) from its Phase 3 ENVISION trial in patients who achieved complete response (CR) at three months after the first instillation of investigational drug UGN-102 (mitomycin) for intravesical solution.

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REVBRevelation Biosciences Inc.
RVL-HV02
to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program)
06/13/2024
9:53 AM
Enrollment Update

Revelation Biosciences, Inc announced that it has completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02).

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AEZSAEterna Zentaris Inc
AEZS-130-P02
Childhood-onset Growth Hormone Deficiency (CGHD)
Phase 306/13/2024
9:44 AM
Provided Update

Aeterna Zentaris Inc. announced the clinical completion of its Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency ("CGHD").

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ELYXYB
for acute treatment of migraine with or without aura
06/13/2024
9:07 AM
Poster Presentation

Scilex Holding Company announced it will be presenting a poster on ELYXYB® (celecoxib oral solution) at the 66th Annual Scientific Meeting of the American Headache Society (AHS) to be held in San Diego, CA on June 13-16, 2024.

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CER-1236
for Ovarian Cancer
Investigational New Drug (IND)06/13/2024
8:24 AM
Regulatory Update

CERo Therapeutics Holdings, Inc announced Company anticipates near term filing of Investigational New Drug Application to FDA

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CER-1236
for Ovarian Cancer
06/13/2024
8:24 AM
Regulatory Update

CERo Therapeutics Holdings, Inc announced it successfully executed pre-IND manufacturing activities for its lead therapeutic, CER-1236.

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CardiolRx
Acute Myocarditis
Phase 206/13/2024
8:16 AM
Top-line data

Cardiol Therapeutics Inc. reported 8-week clinical data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis.

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SONNSonnet BioTherapeutics Holdings Inc
SON-1400
for the treatment of cancers.
06/13/2024
8:10 AM
Provided Update

Sonnet BioTherapeutics Holdings, Inc. announced the generation and in vitro characterization of two novel drug candidates SON-1400 (IL18BPR-FHAB), each containing a modified version of recombinant human interleukin-18 (IL-18BPR).

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SONNSonnet BioTherapeutics Holdings Inc
SON-1411
for the treatment of cancers.
06/13/2024
8:05 AM
Provided Update

Sonnet BioTherapeutics Holdings, Inc announced the generation and in vitro characterization of two novel drug candidates, SON-1411 each containing a modified version of recombinant human interleukin-18 (IL-18BPR).

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NPM-119
for Type 2 Diabetes
Investigational New Drug (IND)06/13/2024
7:19 AM
FDA Clearance

Vivani Medical, Inc. announced that the U.S. FDA has cleared its Investigational New Drug Application for NPM-119, paving the way for the commencement of the LIBERATE-1 Phase 1 trial.

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ALDXAldeyra Therapeutics Inc
Reproxalap
Small-molecule modulator of RASP
Phase 306/13/2024
7:15 AM
Enrollment Update

Aldeyra Therapeutics, Inc. announced the completion of enrollment in a Phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease.

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CTSOCytoSorbents Corp
PuriFi™
hemoperfusion machine
06/13/2024
7:14 AM
Provided Update

CytoSorbents Corporation announces the launch and immediate availability of its PuriFi™ hemoperfusion machine in the E.U., following approval and certification under the E.U. Medical Device Regulation (MDR).

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AZNAZNCFAstraZeneca PLC
FARXIGA (dapagliflozin)
chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D)
FDA Approved06/12/2024
2:06 AM
FDA Approval

AstraZeneca's FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1

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VTP-300
in Chronic Hepatitis B Virus Infections
06/12/2024
2:03 AM
Provided Update

Barinthus Biotherapeutics plc announced plans to prioritize its pipeline to focus on the development of VTP-300 in CHB and VTP-1000 in celiac disease.

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RAREUltragenyx Pharmaceutical Inc
UX111
for Sanfilippo syndrome type A (MPS IIIA)
Meeting With FDA06/12/2024
2:00 AM
FDA Meeting

Ultragenyx Pharmaceutical announced that the company held a successful meeting with the U.S. Food and Drug Administration (FDA or the Agency) during which the company reached agreement with the Agency that cerebral spinal fluid (CSF) heparan sulfate (HS) is a reasonable surrogate endpoint that could support submission of a biologics license application (BLA) seeking accelerated approval for UX111 (ABO-102) AAV gene therapy for the treatment of Sanfilippo syndrome (MPS IIIA).

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PTNPalatin Technologies Inc
Bremelanotide
for the Treatment of Obesity
Phase 206/12/2024
8:41 AM
Study Initiation

Palatin Technologies, Inc. announced the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity.

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CLSDClearside Biomedical Inc
CLS-AX (axitinib injectable suspension
Neovascular age-related macular degeneration (wet AMD)
06/12/2024
7:21 AM
Oral presentation

Clearside Biomedical announced today that multiple oral presentations were delivered at the Clinical Trials at the Summit (CTS) Meeting on June 8, 2024 in Park City, Utah. ,

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RNAAvidity Biosciences Inc
AOC 1020
Facioscapulohumeral Muscular Dystrophy (FSHD)
Phase 1/206/12/2024
7:18 AM
Positive Data

Avidity Biosciences, Inc. announced positive initial AOC 1020 data from the Phase 1/2 FORTITUDE™ trial demonstrating unprecedented and consistent reductions of greater than 50% in DUX4 regulated genes, trends of functional improvement, and favorable safety and tolerability in people living with facioscapulohumeral muscular dystrophy (FSHD).

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DNTH103
In Generalized Myasthenia Gravis (gMG)
Investigational New Drug (IND)06/12/2024
7:14 AM
FDA Clearance

Dianthus Therapeutics, Inc announced U.S. Food and Drug Administration (FDA) clearance of its Phase 2 Investigational New Drug (IND) application for the MoMeNtum trial of DNTH103 in patients with Multifocal Motor Neuropathy (MMN).

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BLTEBelite Bio, Inc.
Tinlarebant
in Stargardt Disease
06/12/2024
4:09 AM
Designation Grant

Belite Bio announces that its lead pipeline, Tinlarebant, has been granted Sakigake Designation by the Ministry of Health, Labour and Welfare in Japan (MHLW) for the treatment of STGD1.

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RAREUltragenyx Pharmaceutical Inc
UX143 (setrusumab)
Osteogenesis Imperfecta (OI)
Phase 206/11/2024
1:47 AM
Positive Results

Ultragenyx Pharmaceutical Inc. announced positive 14-month results from the Phase 2 portion of the ongoing Phase 2/3 Orbit study (NCT05125809) demonstrating that, as of a May 24, 2024 data cut-off date, treatment with setrusumab (UX143) continued to significantly reduce incidence of fractures in patients with OI with at least 14 months of follow-up.

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VTGNVistaGen Therapeutics Inc
Fasedienol
for the acute treatment of social anxiety disorder (SAD).
06/11/2024
1:44 AM
Provided Update

Vistagen announced that "Vistagen's fiscal 2024 proved to be a year full of remarkable accomplishments. Most notably, with our PALISADE-2 trial of fasedienol, we became the first company to report positive results of a Phase 3 trial for the acute treatment of social anxiety disorder, a mental health disorder affecting the lives of over 30 million adults in the U.S for which there is no FDA-approved acute treatment option.

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Vitamin K Antagonist
oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks
06/11/2024
1:42 AM
Provided Update

Cadrenal Therapeutics, Inc., announced that the Company will be participating in the Emerging Growth Conference on June 12, 2024.

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CAPRCapricor Therapeutics Inc
CAP-1002
Duchenne muscular dystrophy
Type B Meeting06/11/2024
10:05 AM
FDA Meeting

Capricor Therapeutics announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).

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Lomecel-B™
Treatment of HLHS
Phase 2b06/11/2024
9:03 AM
Provided Update

Longeveron Inc announced the successful completion of an investigator meeting for ELPIS II, the on-going Phase 2b clinical trial evaluating Lomecel-B™ as a potential adjunct treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric congenital heart birth defect.

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ATNMActinium Pharmaceuticals Inc
Actimab-A + CLAG-M
Relapsed or Refractory Acute Myeloid Leukemia
Phase 1b06/11/2024
8:36 AM
Data

Actinium Pharmaceuticals, Inc. today highlighted data from the completed Phase 1b combination trial of Actimab-A + CLAG-M in patients with relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting held June 8 – 11, 2024, in Toronto, Canada.

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PCSAProcessa Pharmaceuticals Inc
PCS6422
Advanced, Refractory Gastrointestinal Tract Tumors
Phase 1b06/11/2024
8:35 AM
Efficacy Data

Processa Pharmaceuticals, announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial which defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for Next Generation Capecitabine (NGC-Cap) administered to patients with Stage III or IV gastrointestinal tract (GI) cancer.

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Interleukin-2
n patients with mild-to-moderate Alzheimer's Disease
06/11/2024
8:33 AM
Publication

Coya Therapeutics, Inc announces the publication of a peer-reviewed manuscript titled, "A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis," in the medical journal Frontiers in Neurology

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TIZAFTLSATiziana Life Sciences PLC
Foralumab
Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Fast Track Designation06/11/2024
8:31 AM
Regulatory Update

Tiziana Life Sciences, Ltd. announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).

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PCYOPure Cycle Corp
PureFive™
Ultra-Pure Recycled resin is suitable for use in food-contact applications.
06/11/2024
8:28 AM
Regulatory Update

PureCycle Technologies, Inc. announced the receipt of a Letter of No Objection (LNO) from the United States Food & Drug Administration (FDA) confirming that the Company's PureFive™ Ultra-Pure

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RewinD-LB
in patients with dementia with Lewy bodies (DLB).
Phase 2b06/11/2024
8:26 AM
Enrollment Update

CervoMed Inc announced that it has completed enrollment in RewinD-LB, a Phase 2b trial evaluating neflamapimod in patients with dementia with Lewy bodies (DLB).

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TCONTRACON Pharmaceuticals Inc
TRC102 + Chemoradiation
stage III Non-squamous Oon-small cell lung cancer
Phase 206/11/2024
8:24 AM
Clinical Data

TRACON Pharmaceuticals announced the publication of Phase 2 clinical data of its DNA damage repair inhibitor drug candidate, TRC102, in patients with glioblastoma in Clinical Cancer Research.

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Obicetrapib
CETP inhibitor
06/11/2024
8:20 AM
Regulatory Update

NewAmsterdam Pharma Company N.V announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 12,006,305, titled "Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof."

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tafenoquine
for treatment of babesiosis
Orphan Drug Designation06/11/2024
8:17 AM
Designation Grant

60 Degrees Pharmaceuticals, announced today that the U.S. Food and Drug Administration ("FDA") has granted its investigational tafenoquine candidate orphan drug designation for the treatment of patients with acute babesiosis.

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REGNRegeneron Pharmaceuticals Inc
sarilumab
for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
06/11/2024
8:14 AM
FDA Approval

Regeneron Pharmaceuticals, Inc and Sanofi announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time.

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NNVCNanoviricides Inc
NV-387
for MPox and Smallpox virus infections
06/11/2024
6:58 AM
Provided Update

NanoViricides, Inc reports that its clinical stage lead nanoviricide broad-spectrum antiviral drug candidate, NV-387, results in an ideal flat blood concentration profile for an extended time period upon oral administration in two different animal models.

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SAGESage Therapeutics Inc
SAGE-718
in the Treatment of Mild Cognitive Impairment in Parkinson's Disease
06/11/2024
6:56 AM
Endpoint Met

Sage Therapeutics announced The study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington's Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo.

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SAGESage Therapeutics Inc
SAGE-718
in the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Phase 206/11/2024
6:55 AM
Top-line results

Sage Therapeutics announced today topline results from the Phase 2 SURVEYOR Study.

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VRDNViridian Therapeutics, Inc.
VRDN-003
for patients with moderate-to-severe TED.
Phase 306/11/2024
6:53 AM
Clinical Trial

Viridian Therapeutics, Inc today reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe TED.

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IPSEFIPSEYGNFTGNFTFIpsen SA
Genfit SA
elafibranor
for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).
06/10/2024
4:06 AM
FDA Approval

Ipsen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo may be prescribed immediately in the U.S. for eligible patients.

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ARQTArcutis Biotherapeutics Inc
roflumilast
to treat inflammatory dermatoses
06/10/2024
1:58 AM
Results

Arcutis Biotherapeutics, Inc. announced new results from the INTEGUMENT-OLE long-term open-label study of investigational once-daily roflumilast cream 0.15% in adults and children ages 6 years and older with AD presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference.

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INVVYIZQVFIndivior PLC
INDV-2000
to a non-opioid treatment.
Phase 206/10/2024
1:56 AM
Dose Update

Indivior PLC announced the dosing of the first subject with INDV-2000 in a Phase 2 double-blind, placebo controlled, randomized, dose-ranging study to assess the safety and efficacy of INDV-2000 over 3 months in treatment-seeking individuals with Opioid Use Disorder (OUD) (NCT06384157).

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eRapa
in Familial Adenomatous Polyposis
Phase 206/10/2024
8:49 AM
Data Presentation

Biodexa Pharmaceuticals PLC, announces that 12 month data of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis ("FAP") are to be presented at the prestigious biennial InSIGHT 2024 meeting in Barcelona, Spain on June 22, 2024. Carol Burke, MD, the Principal Investigator, will present the six and 12 month data (NCT04230499) in an oral presentation at the meeting. Dr Burke presented the six-month data at the Digestive Disease Weekly meeting in Washington D.C. on May 21, 2024.

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RCUSArcus Biosciences Inc
STAR-221
for Metastatic Upper GI Cancers
Phase 306/10/2024
8:46 AM
Enrollment Update

Arcus Biosciences, Inc announced the completion of patient enrollment for STAR-221, a Phase 3 study in collaboration with Gilead Sciences, evaluating the combination of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.

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SRZNSurrozen Inc.
SZN-043
Severe Alcoholic Hepatitis
Phase 1a06/10/2024
8:43 AM
Poster Presentation

Surrozen presented a poster on the preliminary results of a Phase 1a study of SZN-043, a novel R-Spondin mimetic, in healthy volunteers and subjects with liver cirrhosis on June 8, 2024 at the 2024 European Association for the Study of the Liver (EASL) in Milan

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SLSSELLAS Life Sciences Group Inc
SLS009
for Treatment of Acute Myeloid Leukemia
Phase 2a06/10/2024
8:41 AM
Enrollment Update

SELLAS Life Sciences Group, Inc. announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

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VERUVeru Inc
Enobosarm
ER+/HER2- breast cancer
06/10/2024
8:39 AM
Presentation

Veru Inc announced that the Company will present two presentations at the American Diabetes Association's 84th Scientific Sessions, taking place June 21-24, 2024, in Orlando, Florida.

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Ketamir-2
to treat depression and treatment-resistant depression (TRD).
06/10/2024
8:37 AM
Positive Results

MIRA Pharmaceuticals, Inc announced positive preclinical study results highlighting the potential efficacy and safety profile of Ketamir-2, MIRA's novel oral ketamine analog designed to treat depression and treatment-resistant depression (TRD)..

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ATNMActinium Pharmaceuticals Inc
Iomab-B
Active Relapsed or Refractory Acute Myeloid Leukemia
06/10/2024
8:36 AM
Data

Actinium Pharmaceuticals, Inc today highlighted data from multiple abstracts that were presented at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting being held June 8 – 11, 2024, in Toronto, Canada. .

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ABTAbbott Laboratories
Libre Rio
for people with diabetes
06/10/2024
8:16 AM
FDA Clearance

Abbott announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2.

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ABTAbbott Laboratories
Lingo
to improve their overall health and wellness.
06/10/2024
8:15 AM
FDA Clearance

Abbott announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2.

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LPCNLipocine Inc
LPCN 1148
Liver cirrhosis
Phase 206/10/2024
8:13 AM
Results

Lipocine Inc announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy.

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MLTXMoonLake Immunotherapeutics AG
Sonelokimab
Moderate-to-severe hidradenitis suppurativa
Phase 206/10/2024
8:12 AM
Positive Feedback

MoonLake Immunotherapeutics announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake's proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis (PsA).

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BRSYFBWAYBrainsway Ltd
Deep TMS
Decreasing Anxiety Symptoms in Depressed Patients
06/10/2024
7:35 AM
Clinical Trial

BrainsWay Ltd. announced the initiation of a prospective, randomized, controlled, multicenter clinical trial evaluating an accelerated treatment protocol for the Company's proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) system to treat major depressive disorder (MDD).

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STTKShattuck Labs Inc
SL-172154
for the treatment of AML
Orphan Drug Designation06/10/2024
7:33 AM
Designation Grant

Shattuck Labs, Inc announced that the U.S. FDA has granted orphan drug designation (ODD) to lead clinical candidate SL-172154 for the treatment of AML.

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AZNAZNCFAstraZeneca PLC
TAGRISSO® (osimertinib)
third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
supplemental New Drug Application (sNDA) Priority Review06/10/2024
7:11 AM
FDA Accepted

AstraZeneca's supplemental New Drug Application (sNDA) forTAGRISSO®(osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT).

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REGEN-007
in patients with CKD caused by diabetes
Phase 206/10/2024
6:35 AM
Positive Results

ProKidney Corp. announced positive interim results from the Phase 2 REGEN-007 trial evaluating the Company's renal autologous cell therapy, rilparencel, in patients with CKD caused by diabetes and provided clinical and operational updates. Management will host a live webcast today at 8:00 a.m. ET to discuss the data.

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JAZZJazz Pharmaceuticals PLC
Zanidatamab
In HER2+/HR+ Metastatic Breast Cancer
06/10/2024
6:06 AM
Regulatory Update

Zymeworks Inc announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC.

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licaminlimab
Transform the Treatment Paradigm of Dry Eye Disease with a Precision Medicine Strategy
Phase 2b06/10/2024
5:05 AM
Top-line results

Oculis Holding AG announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED).

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BIIBBiogen Inc
LEQEMBI® (lecanemab-irmb)
Treatment of Alzheimer's Disease
supplemental Biologics License Applications (sBLA)06/09/2024
2:16 AM
FDA Accepted

Biogen Inc and Eisai Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing.

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LLYEli Lilly and Co
tirzepatide
For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Phase 206/08/2024
2:19 AM
Results

Eli Lilly and Company announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis.

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FDMT4D Molecular Therapeutics Inc
4D-150
Wet AMD and diabetic macular edema
Phase 206/08/2024
2:18 AM
Presentation

- 4D Molecular Therapeutics today presented supplemental aflibercept injection-free subgroup analyses of the previously reported 24-week landmark results from the randomized Dose Expansion cohort from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients with severe disease activity and a high treatment burden.

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JNJJohnson & Johnson
VELYS™ Robotic-Assisted Solution
in Unicompartmental Knee Arthroplasty (UKA).
06/07/2024
2:41 AM
Provided Update

Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA).

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BMRNBiomarin Pharmaceutical Inc
Valoctocogene Roxaparvovec
severe hemophilia A
06/07/2024
2:39 AM
New Data

BioMarin Pharmaceutical Inc announced that new data supporting the long-term safety and efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) will be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand, June 22-26, 2024..

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RHHBFRHHBYRHHVFRoche Holding AG
Evrysdi (risdiplam)
5q spinal muscular atrophy (SMA)
06/07/2024
2:37 AM
Efficacy and Safety Data

Roche Group announced today new 5-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study.

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MRNAModerna Inc
SPIKEVAX (COVID-19 Vaccine, mRNA)
COVID-19 in individuals 18 years of age and older
06/07/2024
2:36 AM
Regulatory Update

Moderna Inc announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1.

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GERNGeron Corp
Imetelstat
telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
06/07/2024
2:34 AM
Regulatory Update

MAIA Biotechnology, Inc announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell's telomeric functions as evidenced by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation.

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AREXVY
Respiratory Syncytial Virus Vaccine, Adjuvanted
06/07/2024
2:32 AM
FDA Approval

GSK plc announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.

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CDXCChromaDex Corp
nicotinamide adenine dinucleotide
for the Treatment of Ataxia Telangiectasia (AT)
Orphan Drug Designation06/07/2024
8:55 AM
Designation Grant

ChromaDex Corp announced that the U.S. Food & Drug Administration (FDA) granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation for NRC, the company's product candidate for the treatment of Ataxia Telangiectasia (AT).

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SSKNStrata Skin Sciences Inc
TheraClear®X
treatment of acne
06/07/2024
8:53 AM
Publication

STRATA Skin Sciences announces the publication of a clinical study titled, " A 7-Week Open-Label Trial Evaluating the Safety and Efficacy of TheraClear®X for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults," in the June 2024 issue of the Journal of Clinical and Aesthetic Dermatology (JCAD). ,

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YMABY-mAbs Therapeutics Inc
GD2-SADA
Positive Solid Tumors
06/07/2024
7:46 AM
Preclinical Data

Y-mAbs Therapeutics, Inc announced that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada.

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ZEALZLDPFZealand Pharma A/S
survodutide
patients with F2 and F3 fibrosis
Phase 206/07/2024
7:42 AM
Results

Zealand Pharma A/S announced that Boehringer Ingelheim has reported breakthrough results from a survodutide Phase 2 trial sub-analysis that demonstrate up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), versus 25.9% with placebo after 48 weeks of treatment [response difference: 38.6% (95% CI 18.1% - 59.1%), p=0.0005]. F2 and F3 patient populations are at increased risk of developing liver-related complications.

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URGNUroGen Pharma Ltd
UGN-102
Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
06/06/2024
3:33 AM
Provided Update

UroGen Pharma Ltd. shared additional details about the upcoming ENVISION virtual data event on Thursday, June 13, 2024, at 11:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

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IMGNABBVImmunogen Inc
AbbVie Inc
ELAHERE (mirvetuximab soravtansine-gynx)
ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells
Phase 206/06/2024
10:13 AM
Top-line results

AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC).

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CRMDCormedix Inc
DefenCath
for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
06/06/2024
10:11 AM
Provided Update

CorMedix Inc. announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years.

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CER-1236
for Ovarian Cancer
06/06/2024
10:06 AM
Provided Update

CERo Therapeutics Holdings, Inc., announces the successful completion of toxicology studies for its lead compound, CER-1236.

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PLRXPliant Therapeutics Inc
Bexotegrast
Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
06/06/2024
10:05 AM
Poster Presentation

Pliant Therapeutics, Inc announced two poster presentations, including a late-breaker, were presented at the European Association for the Study of the Liver (EASL) International Liver Congress™ being held June 5-8, 2024.

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MDGLMadrigal Pharmaceuticals Inc
Resmetirom (MAESTRO-NASH)
non-alcoholic steatohepatitis (NASH) and liver fibrosis
Phase 306/06/2024
10:03 AM
Results

Madrigal Pharmaceuticals, Inc announced results from new analyses of the Phase 3 MAESTRO-NASH trial of Rezdiffra being presented at the EASL Congress, which takes place from June 5-8, 2024 in Milan, Italy.

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TNXPTonix Pharmaceuticals Holding Corp
TNX-1500
Humanized monoclonal antibody
06/06/2024
10:02 AM
Oral presentation

Tonix Pharmaceuticals Holding Corp. announces two oral presentations and a poster presentation at the American Transplant Congress 2024, held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. A copy of the oral and poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

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OCUPOcuphire Pharma Inc
APX3330 (ZETA-1)
Diabetic Retinopathy
06/06/2024
10:00 AM
Provided Update

Ocuphire Pharma, Inc announced that clinical updates on the Company's lead candidate APX3330 for diabetic retinopathy (DR) will be featured in upcoming presentations at the Clinical Trials at the Summit meeting on June 8 in Park City, Utah, and the Retinal Imaging Biomarkers & Endpoints Summit meeting June 25-27 in Boston.

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FDMT4D Molecular Therapeutics Inc
4D-710
Cystic fibrosis lung disease
Phase 1/206/06/2024
9:56 AM
Positive Data

4D Molecular Therapeutics announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis (CF) lung disease.

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SNDXSyndax Pharmaceuticals Inc
Revumenib
Relapsed/Refractory KMT2Ar Acute Leukemia
Phase 1b06/06/2024
7:17 AM
Provided Update

Syndax Pharmaceuticals announced that it has advanced into the Phase 1b portion of its Phase 1/2 proof-of-concept trial of revumenib, the Company's highly selective, oral menin inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) metastatic microsatellite stable (MSS) colorectal cancer (CRC).

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REPLReplimune Group Inc
RP1 + Opdivo (nivolumab) - (IGNYTE)
Melanoma / NSCLC
06/06/2024
7:15 AM
Top-line results

Replimune Group, Inc announced the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. .

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PSTIPluristem Therapeutics Inc
PLX-R18
Incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT)
06/06/2024
7:14 AM
Provided Update

Pluri Inc announced the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has exercised its option for year two of the three-year $4.2 million contract it entered into with Pluri in July 2023.

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KALVKalVista Pharmaceuticals Inc
sebetralstat
therapy for hereditary angioedema (HAE).
06/06/2024
7:13 AM
Provided Update

KalVista Pharmaceuticals, Inc announced that it presented the US subgroup analysis from the sebetralstat phase 3 KONFIDENT trial and real-world claims and patient survey data at the Eastern Allergy Conference (EAC) 2024, as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024. KONFIDENT is the first pivotal phase 3 trial to include Japanese sites in an HAE development program.

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ZEALZLDPFZealand Pharma A/S
BI 456906
Obesity and Non-Alcoholic SteatoHepatitis (NASH)
Phase 206/06/2024
7:09 AM
Positive Results

Zealand Pharma A/S announced that an embargoed abstract of positive results from Boehringer Ingelheim's Phase 2 trial of survodutide (BI 456906) in metabolic dysfunction-associated steatohepatitis (MASH) due to be presented at the European Association of the Study of Liver Congress (EASL) 2024 on June 7 was unintentionally and temporarily made available through the congress website.

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denifanstat
for Liver Diseases
Phase 2b06/06/2024
7:08 AM
Positive Data

Sagimet Biosciences Inc. presented positive data from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients at the European Association for the Study of the Liver (EASL) Congress being held in Milan, Italy.

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GILDGilead Sciences Inc
Bulevirtide
Hepatitis delta virus (HDV)
Phase 2b06/06/2024
7:07 AM
Data

Gilead Sciences, Inc. announced data from the Phase 2b MYR204 open-label study assessing the efficacy and safety of the first-in-class entry inhibitor bulevirtide as monotherapy and in combination with pegylated interferon alfa-2a (PegIFN), in adults living with compensated chronic hepatitis delta virus (HDV) infection.

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HRMYHarmony Biosciences Holdings Inc
pitolisant
for the treatment of excessive daytime sleepiness
Phase 206/05/2024
9:24 AM
Data Presentation

Harmony Biosciences presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) and fatigue in adults with Myotonic dystrophy Type 1 (DM1).

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ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
06/05/2024
9:07 AM
Dose Update

Adial Pharmaceuticals Inc announced that the first patient had been dosed in a pharmacokinetics study of AD04 for Alcohol Use Disorder in heavy drinking patients.

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VYNEVYNE Therapeutics Inc
VYN201
Vitiligo
Phase 2b06/05/2024
9:05 AM
Dose Update

VYNE Therapeutics Inc. announced that the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration.

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ARQTArcutis Biotherapeutics Inc
roflumilast
to treat inflammatory dermatoses
06/05/2024
9:03 AM
Abstract

Arcutis Biotherapeutics, Inc. announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis.

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AXSMAxsome Therapeutics Inc
solriamfetol
treatment for attention deficit hyperactivity disorder (ADHD) in adults.
06/05/2024
7:39 AM
Provided Update

Axsome Therapeutics, Inc. announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol).

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VRON-0200
for chronic HBV infection.
06/05/2024
7:14 AM
Provided Update

Ocean Biomedical, Inc today congratulates its JV partner Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies, on its late breaker presentation highlighting the first-ever human immunogenicity data from its novel checkpoint modifier immunotherapy for HBV functional cure (VRON-0200), at the EASL 2024 Congress (The European Association for the Study of the Liver), taking place in Milan, Italy from June 5 - 8.

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IMABI-MAB
TJ-CD4B
Solid Tumors
06/05/2024
7:12 AM
Provided Update

I-Mab announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb's immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

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CANFCan-Fite BioPharma Ltd
Namodenoson (CF102) Liver Cancer
Advanced liver cancer
06/05/2024
7:10 AM
Provided Update

Can-Fite BioPharma Ltd announced an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer.

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ACETAdicet Bio Inc
ADI-001
B cell non-Hodgkin's lymphoma (NHL)
Fast Track Designation06/05/2024
7:09 AM
Designation Grant

Adicet Bio, Inc announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.

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HROWHarrow Health Inc
VEVYE
for treating both the signs and symptoms of dry eye disease (DED).
06/05/2024
7:07 AM
Results

Harrow announce results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of dry eye disease (DED).

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MNOVMediciNova Inc
MN-166 (ibudilast)
Alcohol Use Disorder
06/05/2024
7:06 AM
Provided Update

MediciNova, Inc announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis in various cancers including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, melanoma, and ovarian cancer.

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AUPAUPHAurinia Pharmaceuticals Inc
LUPKYNIS (voclosporin)
Lupus Nephritis
06/05/2024
7:05 AM
Oral presentation

Aurinia Pharmaceuticals Inc announced an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 taking place in Vienna, Austria June 12-15.

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CBAYCymaBay Therapeutics Inc
seladelpar
for the Treatment of Primary Biliary Cholangitis Including Pruritus
06/05/2024
7:03 AM
Interim Results

Gilead Sciences, Inc. announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease. The two-year interim analysis includes people living with PBC who participated in any prior clinical studies of seladelpar (legacy studies) and participants from the pivotal Phase 3 RESPONSE study.

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NNVCNanoviricides Inc
NV-387
for MPox and Smallpox virus infections
06/04/2024
6:59 AM
Provided Update

NanoViricides, Inc. reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a non-human primate (NHP) animal model.

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LUMOLumos Pharma Inc
LUM-201
Pediatric growth hormone deficiency (PGHD)
06/04/2024
9:33 AM
Provided Update

Lumos Pharma, Inc. announced today details of new analyses of data from its Phase 2 OraGrowtH212 clinical trial presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO), held in Boston, MA, June 1-4, 2024. The posters were presented in parallel sessions on Monday June 3, 2024.

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CAPRCapricor Therapeutics Inc
CAP-1002
Duchenne muscular dystrophy
Phase 306/04/2024
9:31 AM
Positive Results

Capricor Therapeutics announced positive 3-year results from the ongoing HOPE-2 open-label extension (OLE) study with CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).

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SILOSILO Pharma Inc
SPC-15
Treatment for PTSD
Investigational New Drug (IND)06/04/2024
9:30 AM
Regulatory Update

Silo Pharma, Inc. announced its submission of a pre-Investigational New Drug (pre-IND) briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15, Silo's intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.

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GHGuardant Health Inc
Guardant360
Advanced solid tumors.
06/04/2024
9:29 AM
Provided Update

Guardant Health, Inc. announced the launch of a new version of its Guardant360 TissueNext test that expands the number of genes it identifies in a tumor tissue sample to 498.

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EQEquillium Inc
EQ101
in adult patients with moderate, severe or very-severe alopecia areata (AA),
Phase 206/04/2024
9:27 AM
Top-line results

Equillium Inc announced positive topline data from its Phase 2, single dose, proof-of-concept (PoC) study of EQ101 in adult patients with moderate, severe or very-severe alopecia areata (AA), an autoimmune disease driven by an immune cell attack of the hair follicles that causes hair loss.

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CUECue Biopharma Inc
CUE-101
HPV+ recurrent/metastatic head and neck cancer
Phase 106/04/2024
9:26 AM
Data

Cue Biopharma, announced updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101.

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BIVIBioVie Inc
Bezisterim
for Parkinson's Disease Patients
06/04/2024
9:25 AM
Provided Update

BioVie Inc. announced the formation of a long COVID Advisory Board that will provide the Company with strategic guidance on the design and execution of a Phase 2b trial in patients with long COVID, with funding from the U.S. Department of Defense.

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BMYBMYMPBristol-Myers Squibb Company
Opdivo (nivolumab)
resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Phase 306/04/2024
9:22 AM
Presentation

Bristol Myers Squibb announced the first presentation of results from the Phase 3 CheckMate -9DW trial evaluating the dual immunotherapy combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) compared to investigator's choice of lenvatinib or sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).

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BBIOBridgeBio Pharma Inc
Infigratinib (PROPEL 2)
Achondroplasia (ACH)
Phase 206/04/2024
9:21 AM
Positive Results

BridgeBio Pharma, Inc. announced sustained positive results from PROPEL 2, a Phase 2 trial of the investigational therapy infigratinib in children with achondroplasia, demonstrating continued potential best-in-class efficacy and an encouraging safety profile.

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ANNXAnnexon Inc
ANX005
Huntington’s Disease (HD)
Phase 306/04/2024
9:19 AM
Positive Results

Annexon, Inc. nnounced positive topline results from its randomized placebo-controlled pivotal Phase 3 trial in patients with Guillain-Barré syndrome (GBS).

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GLYCGlycoMimetics Inc
Uproleselan + Venetoclax + Azacitidine
Older or unfit patients with treatment-naïve acute myeloid leukemia (AML)
Phase 306/04/2024
9:11 AM
Results

GlycoMimetics, Inc. announced comprehensive results from the company's pivotal Phase 3 study of uproleselan in R/R AML.

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CTSOCytoSorbents Corp
CytoSorb
Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)
06/04/2024
9:08 AM
Data Presentation

CytoSorbents Corporation announces the recent data presentation entitled "Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry," at the international EuroPCR 2024 conference in Paris, France - the world-leading course in interventional cardiovascular medicine with over 12,000 attendees - where it was also selected as a top 5 finalist in the best scientific abstract competition.

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IPHAIPHYFInnate Pharma SA
Lacutamab
treatment of patients with relapsed or refractory Sézary syndrome
Phase 206/04/2024
3:56 AM
Results

Innate Pharma SA announced favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF). The results were presented at the ASCO 2024 Annual Meeting, in Chicago, Illinois.

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SGENGMABGNMSFSeagen Inc
Genmab A/S
Tisotumab Vedotin
Recurrent or Metastatic Cervical Cancer
Phase 206/03/2024
4:44 AM
Data

Genmab A/S announced today that data from the Phase 2 innovaTV 207 trial (NCT03485209) Part C (n=40), investigating tisotumab vedotin, an antibody-drug conjugate directed to tissue factor, demonstrated encouraging antitumor activity as a monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on or after first-line therapy.

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PGENPrecigen Inc
PRGN-2012
Recurrent Respiratory Papillomatosis (RRP)
Phase 1/206/03/2024
4:41 AM
Results

Precigen, today released positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse® gene therapy in patients with recurrent respiratory papillomatosis (RRP)

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GILDGilead Sciences Inc
Tecartus (brexucabtagene autoleucel)
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
06/03/2024
4:38 AM
Data

Kite, a Gilead Company announced updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

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BMYBMYMPBristol-Myers Squibb Company
Breyanzi (lisocabtagene maraleucel)
Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Phase 306/03/2024
4:36 AM
Data

Bristol Myers Squibb announced data from three studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzias a second-line treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL), results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trialin relapsed or refractory follicular lymphoma (FL).

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KMPHKemPharm Inc
KP1077
Idiopathic hypersomnia (IH)
06/03/2024
4:31 AM
Positive Results

Zevra Therapeutics, Inc. announced that final positive results from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate or SDX) in patients with idiopathic hypersomnia (IH) were presented in a poster at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held in Houston, TX, June 1-5, 2024.

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CRNXCrinetics Pharmaceuticals Inc
CRN04894
Cushing's disease and Congenital Adrenal Hyperplasia (CAH)
06/03/2024
4:29 AM
Findings Update

Crinetics Pharmaceuticals, Inc. announced initial findings from the development program of its second clinical product candidate, atumelnant* (CRN04894), a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist.

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AOST-2121
in patients with resected, recurrent osteosarcoma.
06/03/2024
4:15 AM
Clinical Update

OS Therapies announced a positive clinical update for AOST-2121 (NCT04974008), its ongoing Phase 2b clinical trial of its immunotherapy OST-HER2 (OST31-154) in patients with resected, recurrent osteosarcoma.

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PBYIPuma Biotechnology Inc
alisertib
for the Treatment of Small Cell Lung Cancer
06/03/2024
4:13 AM
Presentation

Puma Biotechnology, Inc announced the presentation of alisertib for the treatment of patients with advanced osimertinib-resistant epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NCT04085315) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting currently being held in Chicago

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LEGNLegend Biotech Corp
Ciltacabtagene Autoleucel (cilta-cel)
Relapsed and/or Refractory Multiple Myeloma
Phase 206/03/2024
4:10 AM
Results

Legend Biotech Corporation announced today results for the first time from the Phase 2 CARTITUDE-2 Cohort D study in multiple myeloma patients.

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SRRKScholar Rock Holding Corp
SRK-181
Locally advanced or metastatic solid tumors
Phase 106/03/2024
4:09 AM
Data

Scholar Rock announced encouraging data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selective inhibitor of latent TGFβ1 activation, in combination with pembrolizumab in patients with advanced solid tumors.

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FGENFibroGen Inc
FG-3165
for treatment of solid tumors characterized by high Gal9 levels of expression.
Investigational New Drug (IND)06/03/2024
4:05 AM
FDA Clearance

FibroGen announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.

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REGNSNYSNYNFRegeneron Pharmaceuticals Inc
Sanofi SA
Libtayo (cemiplimab)
Advanced Cervical Cancer
06/03/2024
4:03 AM
Provided Update

FibroGen, Inc announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen's immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors.

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COYA 302
for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
06/03/2024
9:38 AM
Provided Update

Coya Therapeutics, Inc. announces the acceptance of a peer-reviewed manuscript titled, "A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis," in the medical journal Frontiers in Neurology.

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ANABGLAXFGSKAnaptysBio Inc
GlaxoSmithKline PLC
JEMPERLI (dostarlimab-gxly)
Recurrent or Advanced dMMR/MSI-H Endometrial Cancer
Phase 206/03/2024
9:35 AM
Provided Update

GSK plc announced updated, longer-term results from the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) evaluating Jemperli (dostarlimab-gxly) as a first-line treatment—as an alternative to surgery—for mismatch repair deficient (dMMR) locally advanced rectal cancer.

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DNLIDenali Therapeutics Inc
DNL126
for MPS IIIA (Sanfilippo Syndrome Type A)
06/03/2024
9:27 AM
Regulatory Update

Denali Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has selected DNL126 for participation in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.

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MRNAModerna Inc
mRNA-4157/V940 (KEYTRUDA)
provide an additive benefit and enhance T cell-mediated destruction of tumor cells.
06/03/2024
9:23 AM
Presentation

Moderna, announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157).

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TNXPTonix Pharmaceuticals Holding Corp
Tonmya
for the management of fibromyalgia.
Phase 306/03/2024
9:19 AM
New Data

Tonix Pharmaceuticals presented new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla.

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ENLVEnlivex Therapeutics Ltd
Allocetra
Sepsis
Phase 1/206/03/2024
9:17 AM
Provided Update

Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health authorized the initiation of an investigator-initiated, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis.

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NBIXNeurocrine Biosciences Inc
CAHtalyst™
for the Treatment of Congenital Adrenal Hyperplasia
Phase 306/03/2024
9:16 AM
Results

Neurocrine Biosciences, Inc. announced that the primary study results from its CAHtalyst™ Phase 3 study investigating crinecerfont for the treatment of adults ages 18 and older with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal.

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NGN-401
for Rett Syndrome
06/03/2024
9:14 AM
Provided Update

Neurogene Inc. announced that its NGN-401 gene therapy for Rett syndrome has been selected to participate in the U.S. Food and Drug Administration (FDA) Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. As part of the START Program, Neurogene will have opportunities for enhanced communications with the FDA, with the aim to further accelerate the pace of NGN-401's development.

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GSBR-1290
for metabolic and cardiopulmonary diseases
06/03/2024
9:11 AM
Data

Structure Therapeutics announced positive 12-week topline obesity data from its Phase 2a study of GSBR-1290, along with positive topline results from its capsule to tablet PK study. Both studies achieved their primary and secondary objectives.

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ARWRArrowhead Pharmaceuticals Inc
plozasiran
in Patients with Familial Chylomicronemia Syndrome
Phase 306/03/2024
9:08 AM
Positive Results

Arrowhead Pharmaceuticals, Inc. announced topline results from the pivotal Phase 3 PALISADE study of investigational plozasiran in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), a severe genetic disease with significant unmet need and no FDA approved therapies. PALISADE successfully met the primary endpoint of lowering triglycerides and met all key secondary endpoints, including reducing the incidence of acute pancreatitis compared to placebo.

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BRSYFBWAYBrainsway Ltd
Deep TMS
Decreasing Anxiety Symptoms in Depressed Patients
06/03/2024
9:03 AM
Provided Update

BrainsWay Ltd. announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the previous upper age limit of 68.

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QUREuniQure NV
AMT-130
Huntington's Disease
Regenerative Medicine Advanced Therapy (RMAT) Designation06/03/2024
9:00 AM
Designation Grant

uniQure N.V announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational gene therapy AMT-130 for the treatment of Huntington's disease.

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CLD-201
to treat advanced solid tumors."
06/03/2024
8:56 AM
Presentation

Calidi Biotherapeutics Inc. announced the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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LQDALiquidia Corp
YUTREPIA
Inhalation Powder
06/03/2024
8:55 AM
Provided Update

Liquidia Corporation v announced today that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware (District Court) denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that sought to block the launch of Liquidia's YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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IPSCCentury Therapeutics
CNTY-101
Relapsed or refractory CD19 positive B-cell malignancies
Phase 106/03/2024
8:52 AM
Interim Results

Century Therapeutics v

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SBBPXERSStrongbridge Biopharma PLC
Xeris Pharmaceuticals Inc
RECORLEV (levoketoconazole)
endogenous Cushing's syndrome
06/03/2024
8:51 AM
Provided Update

Xeris Biopharma Holdings, Inc. announced it presented a post-hoc analysis from its previously published SONICS study on the effects of levoketoconazole (Recorlev®) in adults with Cushing's syndrome at ENDO 2024 in Boston, June 1-4, 2024.

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Nelitolimod
for patients with liver and pancreatic tumors,
Phase 1b06/03/2024
8:47 AM
Data Presentation

TriSalus Life Sciences, Inc announced that data from its Phase 1b PERIO-02 clinical trial was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place May 31-June 4, 2024, in Chicago, Illinois.

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tildacerfont
classic congenital adrenal hyperplasia (CAH)
Phase 206/03/2024
8:45 AM
Study Results

Spruce Biosciences, Inc. presented results from its Phase 2 POWER study of tildacerfont, a second-generation CRF1 receptor antagonist, for the treatment of polycystic ovary syndrome (PCOS) at the 2024 Annual Meeting of the Endocrine Society (ENDO 2024).

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TAKTKPHFTakeda Pharmaceutical Co Ltd
TAK-861
in patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Phase 2b06/03/2024
8:37 AM
Positive Results

Takeda will present today positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

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AGIOAgios Pharmaceuticals Inc
Mitapivat (ACTIVATE)
PK deficiency who do not receive regular transfusions
Phase 306/03/2024
8:30 AM
Endpoint Met

Agios Pharmaceuticals, announced that the global Phase 3 ENERGIZE-T study of mitapivat in adults with transfusion-dependent (TD) alpha- or beta-thalassemia achieved its primary endpoint of transfusion reduction response. Statistical significance was also achieved for all key secondary endpoints evaluating additional measures of reduction of transfusion burden compared to placebo.

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MNOVMediciNova Inc
MN-166 (ibudilast)
Alcohol Use Disorder
06/03/2024
8:28 AM
Provided Update

MediciNova, Inc., announced that MediciNova's collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual meeting 2024 held May 31- June 4th in Chicago, IL.

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IDYAIDEAYA Biosciences Inc
Darovasertib
Non-metastatic uveal melanoma (UM)
Phase 206/03/2024
8:26 AM
Results

IDEAYA Biosciences, Inc announced updated clinical results from the ongoing investigator-sponsored Phase 2 trial of darovasertib, a first-in-class oral, small molecular inhibitor of protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (UM) and clinical update for Phase 2 company-sponsored neoadjuvant UM study.

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QGENQiagen NV
QIAstat-Dx
respiratory syndromic testing panel
06/03/2024
3:53 AM
Provided Update

QIAGEN announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States.

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AZNAZNCFAstraZeneca PLC
Durvalumab
Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Phase 306/02/2024
7:21 AM
Positive Results

AstraZeneca announced Positive results from the ADRIATIC Phase III trial showed AstraZeneca's IMFINZI®(durvalumab) ​demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo for patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following standard-of-care concurrent chemoradiotherapy (cCRT).

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IVBIYIVBXFInnovent Biologics Inc
Taletrectinib
ROS1-Positive Non-Small Cell Lung Cancer
Phase 206/02/2024
4:08 AM
Results

Innovent Biologics, Inc announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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IVBIYIVBXFInnovent Biologics Inc
Taletrectinib
ROS1-Positive Non-Small Cell Lung Cancer
Phase 206/02/2024
4:06 AM
Results

Innovent Biologics, Inc announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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BCRXBioCryst Pharmaceuticals Inc
ORLADEYO (berotralstat)
hereditary angioedema (HAE)
06/02/2024
4:04 AM
Provided Update

BioCryst Pharmaceuticals, Inc announced new real-world evidence showing that patients with hereditary angioedema (HAE) who have normal C1-inhibitor (HAE-nC1-INH) level and function had a reduction in monthly attack rates after starting oral, once-daily ORLADEYO® (berotralstat). The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain.

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AZNAZNCFAstraZeneca PLC
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
for the treatment of adult patients with unresectable or metastatic HER2 positive
06/02/2024
4:03 AM
Positive Results

Detailed positive results from the DESTINY-Breast06 Phase III trial showed that ENHERTU®(fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer and the overall trial population (patients with HR-positive, HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining] expression) following one or more lines of endocrine therapy.

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AZNAZNCFDSKYFDSNKYAstraZeneca PLC
Daiichi Sankyo Co Ltd
Enhertu (Trastuzumab deruxtecan)
Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
06/02/2024
4:02 AM
Positive Results

Detailed positive results from the DESTINY-Breast06phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard of care chemotherapy in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer and the overall trial population (patients with HR positive, HER2 low and HER2 ultralow [defined as IHC 0 with membrane staining] expression) following one or more lines of endocrine therapy.

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PBYIPuma Biotechnology Inc
alisertib
for the Treatment of Small Cell Lung Cancer
06/02/2024
4:01 AM
Presentation

Puma Biotechnology, Inc. announced the presentation of biomarker findings from a Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer (TBCRC 041; Clinicaltrials.gov identifier NCT02860000) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting currently being held in Chicago.

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AZNAZNCFAstraZeneca PLC
TAGRISSO® (osimertinib)
third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Phase 306/02/2024
3:59 AM
Positive Results

Positive results from the LAURA Phase III trial showed AstraZeneca's TAGRISSO® (osimertinib)demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumors have exon 19 deletions or exon 21 (L858R) mutations, after chemoradiotherapy (CRT) compared to placebo after CRT.

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GMABGNMSFABBVGenmab A/S
AbbVie Inc
Epcoritamab (DuoBody-CD3xCD20)
Follicular Lymphoma (FL)
Phase 1/206/02/2024
3:57 AM
Efficacy and Safety Data

Genmab A/S announced new efficacy and safetydata from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with certain types of follicular lymphoma (FL).

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CRBUCaribou Biosciences, Inc.
CB-010
Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
06/02/2024
3:56 AM
Clinical Data

Caribou Biosciences, Inc. today presented updated clinical data from the ongoing ANTLER Phase 1 trial that indicates a single dose of CB-010, a readily available, off-the-shelf anti-CD19 CAR-T cell therapy with a PD-1 knockout, has the potential to rival the safety, efficacy, and durability of approved autologous CAR-T cell therapies.

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IMMPPRRUFImmutep Ltd
eftilagimod alpha
for cancer and autoimmune disease
06/02/2024
3:55 AM
Provided Update

Immutep Limited announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), through a subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial.

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AFMDAffimed NV
AFM24-102
Solid Tumors
06/01/2024
4:39 AM
Data

Affimed N.V. announced longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the on-going AFM24-102 study in NSCLC.

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BMYBMYMPBristol-Myers Squibb Company
KRAZATI (adagrasib)
for the treatment of patients with previously treated KRASG12C
Phase 306/01/2024
5:08 AM
Results

Bristol Myers Squibb announced results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib)compared to standard of care chemotherapy in patients with locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy.

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SGENPFESeagen Inc
Pfizer Inc
ADCETRIS
prescription medicine directed against the CD30 protein
06/01/2024
5:05 AM
Positive Results

Takeda and Pfizer announced that the German Hodgkin Study Group (GHSG) will present positive results from the Phase 3 HD21 trial evaluating ADCETRIS® (brentuximab vedotin) in combination with chemotherapy as a late-breaking oral presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting (LBA7000) and at the 29th European Hematology Association (EHA) Annual Meeting (S225).

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YMABY-mAbs Therapeutics Inc
naxitamab
for the treatment of cancer
Phase 206/01/2024
4:58 AM
Interim Data

Y-mAbs Therapeutics, Inc announced new interim data from the Phase 2 Trial 201 of naxitamab in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF") in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to bone and/or bone marrow. .

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JAZZJazz Pharmaceuticals PLC
Zanidatamab
In HER2+/HR+ Metastatic Breast Cancer
06/01/2024
4:17 AM
Results

Jazz Pharmaceuticals plc announced long-term follow-up results, including the first-ever overall survival (OS) findings, from the Phase 2b HERIZON-BTC-01 clinical trial of zanidatamab in previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).

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IVBIYIVBXFInnovent Biologics Inc
Taletrectinib
ROS1-Positive Non-Small Cell Lung Cancer
Phase 206/01/2024
4:16 AM
Results

Nuvation Bio Inc announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois.

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YMABY-mAbs Therapeutics Inc
GD2-SADA
Positive Solid Tumors
06/01/2024
4:14 AM
Publication

Y-mAbs Therapeutics, Inc announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL.

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CLPTClearPoint Neuro Inc
ClearPoint Neuro Navigation software.
Software Version 2.1
06/01/2024
4:12 AM
Provided Update

ClearPoint Neuro, Inc. announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1st – Tuesday, June 4th in Nashville.

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KPTIKaryopharm Therapeutics Inc
SIENDO (selinexor)
Endometrial Cancer
06/01/2024
4:11 AM
Presentation

Karyopharm Therapeutics Inc. announced the presentation of updated exploratory subgroup analyses from the SIENDO study (NCT03555422), in patients with advanced or recurrent TP53 wild-type endometrial cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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TEVATEVJFTeva Pharmaceutical Industries Ltd
risperidone
injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
06/01/2024
4:09 AM
Presentation

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced the presentation of seven studies from its long-acting injectable (LAI) schizophrenia research program.

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What is an FDA Calendar?

Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.

Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.

The calendar lists down all key catalysts that can materially impact stocks, including:

  • PDUFA dates, or in other words FDA decision dates
  • Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
  • FDA decisions (approvals/complete response letter/delay)
  • According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
  • FDA’s Advisory Committee, or Adcom, meetings
  • Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
  • Decisions by overseas regulatory agencies
  • Clinical data readouts
  • Presentation of data at various scientific conferences.

The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development. 

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes. 

Biotech Stock Movers

Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.

A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.

Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.

PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.

Stock Movers

Gainers

TickerCompany±%Buy Stock
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Loser

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Frequently Asked Questions

Q

What is an FDA PDUFA date?

A

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.

PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.

A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.

The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.

Q

How long does an FDA approval take?

A

A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.

Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.

Q

How do you find FDA approvals?

A

A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.