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

Get Alert
BRTX-100
Chronic Lumbar Disc Disease
05/07/2025
9:20 AM
Provided Update

BioRestorative Therapies, Inc announced that its Vice President of Research and Development, Francisco Silva, will present an update on its ongoing Phase 2 clinical trial of BRTX-100 in chronic lumbar disc disease (cLDD) at the International Society for Cell & Gene Therapy ("ISCT") 2025 Annual Meeting, taking place May 7 - 10, 2025 in New Orleans, LA.

View
Get Alert
GRI-0621
For the treatment of inflammatory, fibrotic and autoimmune diseases
Phase 2a05/07/2025
9:15 AM
Enrollment Update

GRI Bio, Inc announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

View
Get Alert
URGNUroGen Pharma Ltd
UGN-102
Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Oncologic Drugs Advisory Committee (ODAC)05/07/2025
8:59 AM
FDA Meeting

UroGen announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.

View
Get Alert
OST-HER2
In patients with HER2-expressing solid tumors in breast cancer and other cancers
05/07/2025
8:52 AM
Provided Update

OS Therapies announced the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company's listeria monocytogenes (Lm) cancer immunotherapy platform technology into 2040.

View
Get Alert
NRSNNeuroSense Therapeutics Ltd
PrimeC
Amyotrophic lateral sclerosis
05/07/2025
8:51 AM
Provided Update

NeuroSense Therapeutics Ltd. announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.

View
Get Alert
IINNInspira Technologies OXY B.H.N. Ltd.
ART100
Cardio-Pulmonary Bypass Device
05/07/2025
8:50 AM
Approved

Inspira™ Technologies OXY B.H.N. Ltd. announced that the INSPIRA™ ART100 has been approved by Israel's largest healthcare provider to undergo a clinical validation by leading physicians who intend to use the innovative life-support and diagnostic device during organ transplant procedures.

View
Get Alert
Telomir-1
Potential treatment for age-related conditions
05/07/2025
8:34 AM
New Data

Telomir Pharmaceuticals, Inc. announced new preclinical data showing that its lead oral drug candidate, Telomir-1, reverses multiple hallmarks of cellular decline across several human cell lines.

View
Get Alert
ASMBAssembly Biosciences Inc
ABI-6250
For Hepatitis Delta Virus
05/07/2025
8:30 AM
New Data

Assembly Biosciences, announced new preclinical and in vitro data for two therapeutic candidates featured in poster presentations, including one late-breaker, at the European Association for the Study of the Liver (EASL) Congress, taking place May 7-10, 2025, in Amsterdam, the Netherlands.Inc

View
Get Alert
ACTUActuate Therapeutics Inc
elraglusib
In relapsed/refractory Ewing Sarcoma (r/r EWS).
05/07/2025
8:28 AM
Provided Update

Actuate Therapeutics, Inc. announced that it will host an in-person key opinion leader (KOL) event, during the 2025 American Society of Clinical Oncology (ASCO) annual meeting, to discuss the elraglusib topline clinical data from the randomized Phase 2 study (Actuate-1801 Part 3B).

View
Get Alert
neffy
For Pediatric Patients with Type I Allergic Reactions
05/07/2025
8:27 AM
Provided Update

ARS Pharmaceuticals, Inc. announced neffy® (epinephrine nasal spray) 1 mg is now available to patients and caregivers by prescription across the U.S. In March 2025, the U.S. Food and Drug Administration approved neffy for the treatment of Type I allergic reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.).

View
Get Alert
ANNXAnnexon Inc
ANX007
Geographic Atrophy
05/07/2025
8:27 AM
Presentation

Annexon, Inc. announced presentations on the neuroprotective effect of ANX007, including consistent benefits of C1q inhibition against inflammation and neuronal damage across diseases.

View
Get Alert
IC 100
For Obesity-related Heart Disease
05/07/2025
8:26 AM
Provided Update

ZyVersa Therapeutics, Inc. nnounces significant developments for Inflammasome ASC Inhibitor IC 100

View
Get Alert
PHIOPhio Pharmaceuticals Corp
PH-762 (INTASYL)
Murine colorectal cancer
05/07/2025
8:19 AM
Provided Update

Phio Pharmaceuticals Corp. announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort.

View
Get Alert
ALZNALECAlzamend Neuro, Inc.
Alector Inc
AL001
A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
05/07/2025
7:30 AM
EXCLUSIVE

Alzamend Neuro Tells Benzinga Co. Partners With QMENTA To Advance AI-Powered Imaging For Its Phase II Clinical Trial Of AL001 Study

View
Get Alert
BIVIBioVie Inc
NE3107
Mild to moderate Alzheimer's Disease (AD)
Phase 205/07/2025
8:03 AM
Poster Presentation

BioVie Inc announced that a poster on the rationale and design of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson's disease will be presented in a Guided Poster Tour session at the 30th World Congress on Parkinson's Disease and Related Disorders (IAPRD 2025), being held May 7-10, 2025, in New York City.

View
Get Alert
ARAYAccuray Incorporated
CyberKnife®
For Treatment in Men with Localized Prostate Cancer
05/07/2025
7:38 AM
Data Presentation

Accuray Incorporated announced that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® System in the treatment of prostate cancer at multiple stages of the cancer journey.

View
Get Alert
YMABY-mAbs Therapeutics Inc
DANYELZA (naxitamab-gqgk)
Relapsed/refractory high-risk Neuroblastoma
05/07/2025
7:28 AM
Provided Update

Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) is recommended by the National Comprehensive Cancer Network® ("NCCN") Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a NCCN Category 2A treatment option for high-risk neuroblastoma.

View
Get Alert
DTILPrecision BioSciences Inc
PBGENE-HBV
For chronic hepatitis B virus (HBV)
05/07/2025
7:26 AM
Data Presentation

Precision BioSciences, Inc announced that it will present initial safety data from the Phase 1 ELIMINATE-B trial evaluating PBGENE-HBV program for the treatment of chronic hepatitis B during a late breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress being held May 7-10, 2025, in Amsterdam, Netherlands.

View
Get Alert
VCN-01
Retinoblastoma
05/07/2025
7:25 AM
Outcome

Theriva™ Biologics announced positive topline outcomes from the VIRAGE Phase 2b clinical trial evaluating the Company's lead product candidate VCN-01 (zabilugene almadenorepvec) plus standard-of-care (SoC) chemotherapy gemcitabine/nab-paclitaxel as a first line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) for whom gemcitabine/nab-paclitaxel is the recommended first-line treatment option.

View
Get Alert
LYRALyra Therapeutics Inc
LYR-210
Chronic Rhinosinusitis
Phase 305/07/2025
7:23 AM
Results

Lyra Therapeutics, announced that the Company plans to present results from the 52-week Extension Stage of the ENLIGHTEN 1 Phase 3 study for LYR-210, the Company's lead product candidate for CRS, at the annual Combined Otolaryngology Spring Meetings (COSM 2025) being held May 14-18 in New Orleans.

View
Get Alert
AVIRAtea Pharmaceuticals Inc
Bemnifosbuvir
COVID-19
Phase 205/07/2025
7:22 AM
Results

Atea Pharmaceuticals, Inc. today presented results from the full cohort of patients (n=275) enrolled in its Phase 2 study evaluating the once-daily combination of bemnifosbuvir (BEM), an oral nucleotide NS5B polymerase inhibitor, and ruzasvir (RZR), an oral NS5A inhibitor, for the treatment of hepatitis C virus (HCV).

View
Get Alert
LIVNLivaNova PLC
Aura6000
Obstructive Sleep Apnea
05/07/2025
6:03 AM
Top-line data

LivaNova PLC announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA).

View
Get Alert
AZNAZNCFDSKYFDSNKYAstraZeneca PLC
Daiichi Sankyo Co Ltd
Enhertu (Trastuzumab deruxtecan)
Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
05/07/2025
4:40 AM
Top-line results

AstraZeneca announced that Positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer.

View
Get Alert
ALXNAlexion Pharmaceuticals Inc
ALXN1840
Wilson Disease
05/07/2025
4:18 AM
Efficacy and Safety Data

Monopar Therapeutics Inc. announced that it is presenting today data on the long term efficacy and safety of its ALXN1840 (tiomolybdate choline) drug candidate for Wilson disease at the European Association for the Study of the Liver ("EASL") International Liver Congress 2025, one of the most prominent global conferences in liver disease.

View
Get Alert
ABUSArbutus Biopharma Corp
AB-101
Oral PD-L1 inhibitor
05/07/2025
4:17 AM
Poster Presentation

Arbutus Biopharma Corporation announced the presentation of five posters, including one late-breaker, highlighting imdusiran, its RNAi therapeutic and AB-101, its oral PD-L1 inhibitor, at the European Association for the Study of the Liver (EASL) Congress 2025.

View
Get Alert
GILDGilead Sciences Inc
Bulevirtide
Hepatitis delta virus (HDV)
Phase 305/07/2025
3:55 AM
Results

Gilead Sciences Inc announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT).

View
Get Alert
GILDGilead Sciences Inc
Livdelzi
In people living with PBC and compensated cirrhosis
05/07/2025
3:54 AM
New Data

Gilead Sciences, Inc announced new data from multiple analyses which reinforce that Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history.

View
Get Alert
NRBONeuroBo Pharmaceuticals Inc
DA-1241
G-Protein-Coupled Receptor 119
Phase 2a05/07/2025
3:51 AM
Data

MetaVia Inc. announced that data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), demonstrates both hepatoprotective and glucose-regulating effects.

View
Get Alert
OMEROmeros Corp
Narsoplimab
Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
Biologics License Applications (BLA)05/06/2025
9:16 AM
review

Omeros Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

View
Get Alert
SGMOSangamo Therapeutics Inc
ST-920
FabryDisease
05/06/2025
8:53 AM
Provided Update

Sangamo Therapeutics, Inc announced important derisking events in the pathway to a planned BLA submission for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.

View
Get Alert
RNXTRenovoRx, Inc.
RenovoCath
Solid Tumors
05/06/2025
8:52 AM
Provided Update

RenovoRx, Inc announced that it has received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent NO. 12,290,564, becomes effective today, May 6, 2025.

View
Get Alert
ATNMActinium Pharmaceuticals Inc
Iomab-ACT
In patients with sickle cell disease.
05/06/2025
8:48 AM
Enrollment Update

Actinium Pharmaceuticals, Inc. announced that the first patient was enrolled on the trial studying Iomab-ACT targeted conditioning with a commercial CAR-T therapy at the University of Texas Southwestern Medical Center (UTSW) (NCT06768905).

View
Get Alert
PCRXPacira BioSciences Inc
PCRX-201
For the Treatment of Osteoarthritis of the Knee
Phase 105/06/2025
8:19 AM
New Data

Pacira BioSciences, Inc announced new data from its ongoing Phase 1 study of its gene therapy candidate PCRX-201 (enekinragene inzadenovec).

View
Get Alert
IMNN-001
For ovarian cancer
Phase 1/205/06/2025
8:17 AM
Data

IMUNON, Inc. announced that data from the company's Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology.

View
Get Alert
ARDXArdelyx Inc
tenapanor
Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
05/06/2025
8:16 AM
Data Presentation

Ardelyx, Inc. announced that the company presented data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference (DDW), now underway in San Diego.

View
Get Alert
TH104
For Chronic Pruritis in Primary Biliary Cholangitis (PBC)
Phase 105/06/2025
8:15 AM
Data

Tharimmune released pharmacokinetic and metabolism data from its Phase 1 study of TH104, a buccal film formulation of nalmefene, in healthy subjects.

View
Get Alert
BHCBausch Health Companies Inc
XIFAXAN® (rifaximin)
Indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
05/06/2025
8:14 AM
New Data

Bausch Health Companies Inc. announced new data showing that people hospitalized due to overt hepatic encephalopathy (OHE) had a reduced risk of OHE-related rehospitalization within 30 days if treated with Xifaxan® (rifaximin) following hospital discharge regardless of prior treatment.

View
Get Alert
ECUR-506
For the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency
05/06/2025
8:13 AM
Initial Data

iECURE, Inc announced that initial data from the first participant to complete the ongoing OTC-HOPE clinical trial evaluating in vivo gene editing candidate ECUR-506 in neonatal onset ornithine transcarbamylase (OTC) deficiency will be presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting taking place May 12 – 17, 2025 in New Orleans and the European Society of Human Genetics (ESHG) Conference taking place May 24 – 27, 2025 in Milan, Italy.

View
Get Alert
OCUPOcuphire Pharma Inc
OPGx-LCA5
For LCA5
Regenerative Medicine Advanced Therapy (RMAT) Designation05/06/2025
8:11 AM
Designation Grant

Opus Genetics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber Congenital Amaurosis (LCA) due to genetic variations in the LCA5 gene.

View
Get Alert
ACTUActuate Therapeutics Inc
elraglusib
In relapsed/refractory Ewing Sarcoma (r/r EWS).
05/06/2025
8:10 AM
Primary endpoint Met

Actuate Therapeutics, Inc announced that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).

View
Get Alert
INTSIntensity Therapeutics Inc
INT230-6
treatment for certain soft tissue sarcoma subtypes.
European Medicines Agency (EMA)05/06/2025
8:09 AM
Authorization

Intensity Therapeutics, Inc announced that the European Medicines Agency ("EMA") has authorized the initiation of the INVINCIBLE-4 (SAKK 66/22) ("INVINCIBLE-4 Study") (NCT06358573) in France in collaboration with Unicancer.

View
Get Alert
MIRAMIRA PHARMACEUTICALS, INC.
Ketamir-2
To treat depression and treatment-resistant depression (TRD).
05/06/2025
7:21 AM
EXCLUSIVE

MIRA Pharmaceuticals Tells Benzinga 'Preclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment'

View
Get Alert
PAS-004
Allosteric inhibitor of MEK 1/2
Phase 105/06/2025
7:10 AM
Positive Data

Pasithea Therapeutics Corp. announced positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients.

View
Get Alert
GNPXGenprex Inc
Reqorsa® Gene Therapy
For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
05/06/2025
7:07 AM
Provided Update

Genprex, Inc announced it has entered into an exclusive patent license agreement with UTHealth Houston granting Genprex exclusivity and commercial rights relating to its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid) for the potential treatment of glioblastoma.

View
Get Alert
TIZAFTLSATiziana Life Sciences PLC
Foralumab
Crohn's disease with decreases in the classic side effects of cytokine release syndrome
05/06/2025
7:06 AM
Results

Tiziana Life Sciences, Ltd. announced promising results from an open-label clinical study evaluating nasal foralumab, the world's only fully human anti-CD3 monoclonal antibody administered intranasally, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS).

View
Get Alert
AZNAZNCFAstraZeneca PLC
CALQUENCE
In patients with treatment-naïve CLL.1
European Commission05/06/2025
6:41 AM
Approved

PUBLISHED 6 May 2025 Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival improvement vs. chemoimmunotherapy alone AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant.

View
Get Alert
IDYAIDEAYA Biosciences Inc
IDE849
In Solid Tumors
Investigational New Drug (IND)05/06/2025
6:37 AM
FDA Clearance

IDEAYA Biosciences announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, in solid tumors.

View
Get Alert
VNAPFVRNAVerona Pharma PLC
Ensifentrine
Chronic obstructive pulmonary disease (COPD)
Phase 305/06/2025
6:13 AM
Poster Presentation

Verona Pharma plc announces ten posters including seven additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD"), two from nonclinical studies, and one from a real-world data analysis, will be presented at the American Thoracic Society Conference ("ATS") 2025.

View
Get Alert
CLDXCelldex Therapeutics Inc
Barzolvolimab
For Prurigo Nodularis
Phase 205/05/2025
4:01 PM
Data Presentation

Celldex announced the presentation of histology data from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE).

View
Get Alert
LTRNLantern Pharma Inc
LP-184
Prostate cancer
New Drug Application (NDA)05/05/2025
8:56 AM
EXCLUSIVE

Lantern Pharma Tells Benzinga Co. Advances Drug Candidate LP-184 With IND Clearance For Phase 1b/2 Trial In Triple Negative Breast Cancer

View
Get Alert
MDXGMiMedx Group Inc
EPIFIX
Chronic wounds
05/05/2025
8:54 AM
Publication

MiMedx Group, Inc. announced the publication of its health economics data for reconstruction of cutaneous wounds with EPIFIX® (Dehydrated Human Amnion Chorion Membrane, or DHACM) following Mohs surgery.

View
Get Alert
JANXJanux Therapeutics, Inc.
JANX007
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 1b05/05/2025
8:53 AM
Study Expansion

Janux Therapeutics, Inc. announced the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial.

View
Get Alert
JNJJohnson & Johnson
Guselkumab
For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Phase 305/05/2025
8:52 AM
New Data

Johnson & Johnson announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC).

View
Get Alert
HURATuHURA Biosciences Inc
IFx-Hu2.0
For Metastatic Merkel Cell Carcinoma Of Unknown Primary Origin
Phase 1b/2a05/05/2025
8:50 AM
Trial Initiation

TuHURA Biosciences, announced the initiation of its Phase 1b/2a trial of IFx-Hu2.0, TuHURA's lead innate immune agonist, in patients with MCCUP who would not be eligible for the Company's planned Phase 3 accelerated approval trial, which is targeted to begin enrollment later in Q2 2025.

View
Get Alert
HOWLWerewolf Therapeutics, Inc.
WTX-921
for Inflammatory Diseases
05/05/2025
8:47 AM
Poster Presentation

Werewolf Therapeutics, Inc. announced a poster presentation further characterizing its conditionally-activated IL-10 INDUKINE molecule, WTX-921, at IMMUNOLOGY2025, the annual meeting of the American Association of Immunologists (AAI) taking place May 3-7 in Honolulu, Hawaii.

View
Get Alert
TACTI-003
Treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
05/05/2025
8:46 AM
Provided Update

Immutep Limited announces an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial.

View
Get Alert
NRXPNRx Pharmaceuticals
NRX-100
To treat acute depression and suicidality
05/05/2025
8:45 AM
Provided Update

NRx Pharmaceuticals, Inc. announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression.

View
Get Alert
PTCTPTC Therapeutics Inc
PTC518
Huntington's Disease
Phase 205/05/2025
8:44 AM
Results

PTC Therapeutics, Inc. announced results from the Phase 2 PIVOT-HD study of PTC518 (votoplam) in Stage 2 and Stage 3 Huntington's disease (HD) patients.

View
Get Alert
XCURExicure Inc
burixafor
In Multiple Myeloma
Phase 205/05/2025
8:42 AM
Enrollment Completion

Exicure, Inc. announced it has completed patient enrollment in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).

View
Get Alert
VNDAVanda Pharmaceuticals Inc
Bysanti
For the Treatments of Acute Bipolar I Disorder and Schizophrenia
New Drug Application (NDA)05/05/2025
8:40 AM
NDA Filing

Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified.

View
Get Alert
SPY001
For the Treatment of Inflammatory Bowel Disease
05/05/2025
8:39 AM
Poster Presentation

Spyre Therapeutics, Inc announced two poster presentations at Digestive Disease Week (DDW) 2025, being held May 3-6, 2025, in San Diego, California..

View
Get Alert
RZLTRezolute Inc
Ersodetug
For Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation05/05/2025
8:38 AM
Designation Grant

Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.

View
Get Alert
OCUPOcuphire Pharma Inc
OPGx-LCA5
For LCA5
Phase 1/205/05/2025
8:35 AM
Results

Opus Genetics, Inc. announced one-year results from adult patients treated in the ongoing Phase 1/2 Study of its lead gene therapy candidate OPGx-LCA5.

View
Get Alert
CAPRCapricor Therapeutics Inc
Deramiocel
For the Treatment of Duchenne Muscular Dystrophy
05/05/2025
8:34 AM
FDA Meeting

Capricor Therapeutics announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.

View
Get Alert
CMMBChemomab Therapeutics, Ltd.
CM-101 (PSC)
Primary Sclerosing Cholangitis
Phase 205/05/2025
8:32 AM
Data

Chemomab Therapeutics, Ltd announced that data from the company's Phase 2 SPRING trial of nebokitug (CM-101) in primary sclerosing cholangitis (PSC)1 was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025) in San Diego, California.

View
Get Alert
UBXUnity Biotechnology Inc
UBX1325
Diabetic Retinopathy Eye Diseases
Phase 2b05/05/2025
8:31 AM
Results

UNITY Biotechnology, Inc announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.

View
Get Alert
PTNPalatin Technologies Inc
PL9588
treatments targeting the melanocortin receptor system
05/05/2025
7:40 AM
New Data

Palatin Technologies, Inc. announced new preclinical data for PL9588, a novel melanocortin receptor agonist, presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

View
Get Alert
ATHEPRNAFAlterity Therapeutics Ltd
ATH434
To inhibit the aggregation of pathological proteins implicated in neurodegeneration
Fast Track Designation05/05/2025
7:35 AM
Designation Grant

Alterity Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATH434 for the treatment of Multiple System Atrophy (MSA).

View
Get Alert
ANIPANI Pharmaceuticals Inc
Cortrophin Gel
Injectable Gel
05/05/2025
7:34 AM
Preclinical Data

ANI Pharmaceuticals, Inc. announced preclinical data on the use of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in an EAU mouse model.

View
Get Alert
EPRXEupraxia Pharmaceuticals Inc
EP-104GI
For Treatment of Eosinophilic Esophagitis
05/05/2025
7:28 AM
positive Outcome

Eupraxia Pharmaceuticals Inc. announced positive treatment outcomes from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").

View
Get Alert
EPRXEupraxia Pharmaceuticals Inc
EP-104GI
For Treatment of Eosinophilic Esophagitis
Phase 1b/2a05/05/2025
7:22 AM
positive Outcome

Eupraxia Pharmaceuticals Inc announced positive treatment outcomes from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of eosinophilic esophagitis ("EoE").

View
Get Alert
KMDAKamada Ltd
CYTOGAM
Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV)
05/05/2025
7:26 AM
Provided Update

Kamada Ltd. announced the launch of a new post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM®, the Company's Cytomegalovirus Immune Globulin, in the management of cytomegalovirus (CMV) in solid organ transplantation.

View
Get Alert
SELARSDI
For the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis
05/05/2025
7:25 AM
FDA approved

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab).

View
Get Alert
DNTH103
In Generalized Myasthenia Gravis (gMG)
Phase 205/05/2025
7:24 AM
Enrollment Update

Dianthus Therapeutics, Inc announced completion of enrollment in the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG).

View
Get Alert
ANKTIVA
For Bacillus Calmette-Guérin
Refusal to File (RTF)05/05/2025
7:19 AM
Provided Update

ImmunityBio, Inc. announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease.

View
Get Alert
NBTXNNBXFNanobiotix SA
NBTXR3
For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Phase 105/05/2025
7:17 AM
Presentation

NANOBIOTIX announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer.

View
Get Alert
RXRXRecursion
REC-4881
Familial Adenomatous Polyposis (FAP)
Phase 1b/205/04/2025
7:49 AM
Efficacy and Safety results

Recursion announced preliminary safety and efficacy results from its ongoing Phase 1b/2 TUPELO trial of REC-4881, an investigational, allosteric MEK1/2 inhibitor in development for Familial Adenomatous Polyposis (FAP).

View
Get Alert
neffy
For Pediatric Patients with Type I Allergic Reactions
05/02/2025
4:40 PM
Provided Update

ARS Pharmaceuticals, Inc. announced today that the company has entered into an agreement with ALK-Abelló A/S to co-promote neffy® (epinephrine nasal spray), the only approved needle-free treatment for Type I allergic reactions including anaphylaxis, to up to 9,000 pediatricians.

View
Get Alert
NONOFNVOVERUNovo Nordisk A/S
Veru Inc
Wegovy
For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
New Drug Application (NDA)05/02/2025
4:35 PM
FDA Accepted

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.

Get Alert
PCRXPacira BioSciences Inc
PCRX-201
For the Treatment of Osteoarthritis of the Knee
05/02/2025
4:32 PM
Presentation Update

Pacira BioSciences, Inc. announced an upcoming podium presentation of findings from its Phase 1 study of PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy candidate for osteoarthritis of the knee.

View
Get Alert
AZNAZNCFAstraZeneca PLC
BREZTRI AEROSPHERE
To improve cardiopulmonary outcomes in people with COPD
Phase 305/02/2025
4:30 PM
Positive Results

AstraZeneca announce Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca's fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.

View
Get Alert
ABBVAbbVie Inc
BOTOX (onabotulinumtoxinA)
Upper Limb Spasticity
05/01/2025
5:29 PM
Provided Update

Allergan Aesthetics, an AbbVie company announced BOTOX® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs.

View
Get Alert
CTSOCytoSorbents Corp
DrugSorb-ATR
Antithrombotic Removal System
05/01/2025
5:26 PM
Regulatory Update

CytoSorbents Corporation today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.

View
Get Alert
Epetraborole
For NTM Lung Disease & Melioidosis
Phase 305/01/2025
5:23 PM
Top-line results

AN2 Therapeutics, Inc announced topline results from the Phase 3 portion of the EBO-301 study evaluating epetraborole on top of an optimized background regimen (EBO+OBR) in treatment-refractory MAC lung disease.

View
Get Alert
REGNSNYSNYNFRegeneron Pharmaceuticals Inc
Sanofi SA
Libtayo (cemiplimab)
Advanced Cervical Cancer
05/01/2025
9:35 AM
New Data

Regeneron Pharmaceuticals, Inc. announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, IL.

View
Get Alert
SRNESorrento Therapeutics Inc
SP-102 (SEMDEXA)
Sciatica Pain Management
05/01/2025
9:18 AM
Presentation

Scilex Holding Company announced an upcoming presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL.

View
Get Alert
BCDABioCardia Inc
CardiAMP HF
For Ischemic Heart Failure
Phase 305/01/2025
9:11 AM
Enrollment Update

BioCardia, Inc. announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company's lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida.

View
Get Alert
REGNSNYSNYNFRegeneron Pharmaceuticals Inc
Sanofi SA
Dupixent (dupilumab)
Moderate-to-severe asthma
05/01/2025
9:09 AM
Abstract

Regeneron Pharmaceuticals, Inc. announced 24 abstracts on Dupixent® (dupilumab) clinical data and real-world analyses in respiratory diseases will be presented at the American Thoracic Society (ATS) International Conference 2025 being held from May 18 to 21 in San Francisco, California.

View
Get Alert
LYELLyell Immunopharma, Inc.
IMPT-314
For the treatment of B-cell Lymphoma
Phase 1/205/01/2025
9:04 AM
Abstract

Lyell Immunopharma, Inc. announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.

View
Get Alert
TTX-MC138
In Patients with Advanced Solid Tumors
05/01/2025
8:46 AM
Dose Update

EXCLUSIVE: TransCode Therapeutics Tells Benzinga 'A total of 13 patients treated with four escalating doses of TTX-MC138'

View
Get Alert
ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
05/01/2025
8:10 AM
Provided Update

EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga 'New patent covers a treatment method for a broad spectrum of alcohol-related disorders, including additional conditions associated with alcohol use'

View
Get Alert
ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
05/01/2025
8:09 AM
Provided Update

EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga Co. Expands Intellectual Property Portfolio With New US Patent Granted For Genetic-Based Treatment Of Alcohol And Opioid Use Disorders

View
Get Alert
ATXSAstria Therapeutics, Inc.
Navenibart
For the Treatment of Hereditary Angioedema
Phase 1a05/01/2025
8:08 AM
Results

Astria Therapeutics, Inc. announced that results from a Phase 1a trial in healthy subjects supporting navenibart's potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology.

View
Get Alert
FDMT4D Molecular Therapeutics Inc
4D-150
Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Regenerative Medicine Advanced Therapy (RMAT) Designation05/01/2025
8:06 AM
Designation Grant

4D Molecular Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME).

View
Get Alert
DSGNDesign Therapeutics, Inc.
DT-168
For Fuchs endothelial corneal dystrophy (FECD)
05/01/2025
8:03 AM
Data Presentation

Design Therapeutics, Inc. announced favorable data from a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial of DT-168 in healthy volunteers, which will be presented on May 2, 2025 at Eyecelerator @ Park City 2025, an event backed by the American Academy of Ophthalmology highlighting industry advancements and innovative new products disrupting eye care.

View
Get Alert
EWEdwards Lifesciences Corp
SAPIEN
For Ultra transcatheter heart valve
05/01/2025
8:02 AM
FDA approved

Edwards Lifesciences announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.

View
Get Alert
OK-101
Treatment of Dry Eye Disease
Fast Track Designation05/01/2025
7:41 AM
Designation Grant

OKYO Pharma Limited announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP).

View
Get Alert
AVXLAnavex Life Sciences Corp
ANAVEX®3-71
For the treatment of neurodegenerative and neurodevelopmental disorders
Phase 205/01/2025
7:38 AM
Enrollment Update

Anavex Life Sciences Corp announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213).

View
Get Alert
BPMCBlueprint Medicines Corp
Avapritinib
For Indolent Systemic Mastocytosis
05/01/2025
7:21 AM
Provided Update

Blueprint Medicines Corporation provided corporate updates.

View
Get Alert
BPTHBio-Path Holdings Inc
BP1001
For the treatment of acute myeloid leukemia (AML).
05/01/2025
7:19 AM
Provided Update

Bio-Path Holdings, Inc today reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity.

View
Get Alert
PRTCPTCHFPureTech Health PLC
LYT-100
Idiopathic Pulmonary Fibrosis
05/01/2025
7:14 AM
Late Breaking Presentation

PureTech Health plc announced that the Company will deliver a late-breaking oral presentation at the upcoming American Thoracic Society (ATS) International Conference, taking place in San Francisco, California, from May 16-21, 2025.

View
Get Alert
ALRNAileron Therapeutics Inc
LTI-03
In Idiopathic Pulmonary Fibrosis
05/01/2025
7:12 AM
Provided Update

Rein Therapeutics announced a collaboration for the integration of Qureight's deep-learning platform into Rein's planned Phase 2 trial of its lead asset LTI-03, a novel, multi-pathway, Caveolin-1-related peptide, for the treatment of idiopathic pulmonary fibrosis (IPF).

View
Get Alert

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
Loading...
Get in real-time

Loser

TickerCompany±%Buy Stock
Loading...
Get in real-time

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.