| | 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 2a | 05/07/2025 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 |
URGN | UroGen 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 |
NRSN | NeuroSense 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 |
IINN | Inspira 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 |
ASMB | Assembly 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 |
ACTU | Actuate 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 |
ANNX | Annexon 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 |
PHIO | Phio 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 |
ALZNALEC | Alzamend 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 |
BIVI | BioVie Inc
| NE3107 Mild to moderate Alzheimer's Disease (AD) | Phase 2 | 05/07/2025 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 |
ARAY | Accuray 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 |
YMAB | Y-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 |
DTIL | Precision 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 |
LYRA | Lyra Therapeutics Inc
| LYR-210 Chronic Rhinosinusitis | Phase 3 | 05/07/2025 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 |
AVIR | Atea Pharmaceuticals Inc
| Bemnifosbuvir COVID-19 | Phase 2 | 05/07/2025 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 |
LIVN | LivaNova 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 |
AZNAZNCFDSKYFDSNKY | AstraZeneca 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 |
ALXN | Alexion 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 |
ABUS | Arbutus 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 |
GILD | Gilead Sciences Inc
| Bulevirtide Hepatitis delta virus (HDV) | Phase 3 | 05/07/2025 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 |
GILD | Gilead 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 |
NRBO | NeuroBo Pharmaceuticals Inc
| DA-1241 G-Protein-Coupled Receptor 119 | Phase 2a | 05/07/2025 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 |
OMER | Omeros 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 |
SGMO | Sangamo 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 |
RNXT | RenovoRx, 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 |
ATNM | Actinium 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 |
PCRX | Pacira BioSciences Inc
| PCRX-201 For the Treatment of Osteoarthritis of the Knee | Phase 1 | 05/06/2025 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 1/2 | 05/06/2025 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 |
ARDX | Ardelyx 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 1 | 05/06/2025 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 |
BHC | Bausch 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 |
OCUP | Ocuphire Pharma Inc
| OPGx-LCA5 For LCA5 | Regenerative Medicine Advanced Therapy (RMAT) Designation | 05/06/2025 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 |
ACTU | Actuate 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 |
INTS | Intensity 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 |
MIRA | MIRA 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 1 | 05/06/2025 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 |
GNPX | Genprex 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 |
TIZAFTLSA | Tiziana 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 |
AZNAZNCF | AstraZeneca PLC
| CALQUENCE In patients with treatment-naïve CLL.1 | European Commission | 05/06/2025 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 |
IDYA | IDEAYA 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 |
VNAPFVRNA | Verona Pharma PLC
| Ensifentrine Chronic obstructive pulmonary disease (COPD) | Phase 3 | 05/06/2025 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 |
CLDX | Celldex Therapeutics Inc
| Barzolvolimab For Prurigo Nodularis | Phase 2 | 05/05/2025 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 |
LTRN | Lantern 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 |
MDXG | MiMedx 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 |
JANX | Janux Therapeutics, Inc.
| JANX007 Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Phase 1b | 05/05/2025 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 |
JNJ | Johnson & Johnson
| Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis | Phase 3 | 05/05/2025 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 |
HURA | TuHURA Biosciences Inc
| IFx-Hu2.0 For Metastatic Merkel Cell Carcinoma Of Unknown Primary Origin | Phase 1b/2a | 05/05/2025 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 |
HOWL | Werewolf 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 |
NRXP | NRx 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 |
PTCT | PTC Therapeutics Inc
| PTC518 Huntington's Disease | Phase 2 | 05/05/2025 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 |
XCUR | Exicure Inc
| burixafor In Multiple Myeloma | Phase 2 | 05/05/2025 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 |
VNDA | Vanda 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 |
RZLT | Rezolute Inc
| Ersodetug For Hypoglycemia Due to Congenital Hyperinsulinism | Breakthrough Therapy Designation | 05/05/2025 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 |
OCUP | Ocuphire Pharma Inc
| OPGx-LCA5 For LCA5 | Phase 1/2 | 05/05/2025 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 |
CAPR | Capricor 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 |
CMMB | Chemomab Therapeutics, Ltd.
| CM-101 (PSC) Primary Sclerosing Cholangitis | Phase 2 | 05/05/2025 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 |
UBX | Unity Biotechnology Inc
| UBX1325 Diabetic Retinopathy Eye Diseases | Phase 2b | 05/05/2025 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 |
PTN | Palatin 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 |
ATHEPRNAF | Alterity Therapeutics Ltd
| ATH434 To inhibit the aggregation of pathological proteins implicated in neurodegeneration | Fast Track Designation | 05/05/2025 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 |
ANIP | ANI 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 |
EPRX | Eupraxia 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 |
EPRX | Eupraxia Pharmaceuticals Inc
| EP-104GI For Treatment of Eosinophilic Esophagitis | Phase 1b/2a | 05/05/2025 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 |
KMDA | Kamada 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 2 | 05/05/2025 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 |
NBTXNNBXF | Nanobiotix SA
| NBTXR3 For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC"). | Phase 1 | 05/05/2025 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 |
RXRX | Recursion
| REC-4881 Familial Adenomatous Polyposis (FAP) | Phase 1b/2 | 05/04/2025 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 |
NONOFNVOVERU | Novo 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 |
PCRX | Pacira 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 |
AZNAZNCF | AstraZeneca PLC
| BREZTRI AEROSPHERE To improve cardiopulmonary outcomes in people with COPD | Phase 3 | 05/02/2025 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 |
ABBV | AbbVie 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 |
CTSO | CytoSorbents 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 3 | 05/01/2025 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 |
REGNSNYSNYNF | Regeneron 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 |
SRNE | Sorrento 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 |
BCDA | BioCardia Inc
| CardiAMP HF For Ischemic Heart Failure | Phase 3 | 05/01/2025 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 |
REGNSNYSNYNF | Regeneron 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 |
LYEL | Lyell Immunopharma, Inc.
| IMPT-314 For the treatment of B-cell Lymphoma | Phase 1/2 | 05/01/2025 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 |
ADIL | Adial 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 |
ADIL | Adial 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 |
ATXS | Astria Therapeutics, Inc.
| Navenibart For the Treatment of Hereditary Angioedema | Phase 1a | 05/01/2025 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 |
FDMT | 4D 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) Designation | 05/01/2025 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 |
DSGN | Design 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 |
EW | Edwards 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 Designation | 05/01/2025 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 |
AVXL | Anavex Life Sciences Corp
| ANAVEX®3-71 For the treatment of neurodegenerative and neurodevelopmental disorders | Phase 2 | 05/01/2025 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 |
BPMC | Blueprint Medicines Corp
| Avapritinib For Indolent Systemic Mastocytosis | — | 05/01/2025 7:21 AM | Provided Update | Blueprint Medicines Corporation provided corporate updates. View | Get Alert |
BPTH | Bio-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 |
PRTCPTCHF | PureTech 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 |
ALRN | Aileron 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 |