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Clinical Trial News & Results

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

Xenon Showcases New Long-Term Azetukalner Data from X-TOLE OLE Study

VANCOUVER, British Columbia and BOSTON, Dec. 06, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical...

Phanes Therapeutics’ PT217 Granted Fast Track Designation by the FDA for NEPC

SAN DIEGO, Dec. 4, 2024 /PRNewswire/ — Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and...

FDA Grants Revascor (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease

NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases...

Amylyx Pharmaceuticals Announces Pivotal Phase 3 LUCIDITY Trial Design for GLP-1 Receptor Antagonist (Avexitide) in Post-Bariatric Hypoglycemia

CAMBRIDGE, Mass.--(BUSINESS WIRE) December 04, 2024 -- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today...

Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression

CAMBRIDGE, Mass.--(BUSINESS WIRE) November 12, 2024 -- Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of...

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations

RAHWAY, N.J.--(BUSINESS WIRE) December 3, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food...

Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)

DALLAS--(BUSINESS WIRE) December 03, 2024 -- Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer...

FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer

Dec. 03, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and...

Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm (epinephrine) Sublingual Film

WARREN, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful...

Newer Epilepsy Medications Used During Pregnancy Do Not Affect Neurological Development in Children

November 27, 2024 -- Children of mothers who took certain antiseizure medications while pregnant do not have worse neurodevelopmental outcomes at age 6...

Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007

TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused...

Amgen Announces Robust Weight Loss With MariTide in People Living With Obesity or Overweight at 52 Weeks in a Phase 2 Study

THOUSAND OAKS, Calif., Nov. 26, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive data at 52 weeks in a double-blind, dose-ranging Phase 2...

Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy

NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering innovative...

Cassava Sciences Topline Phase 3 Data for Simufilam Did Not Meet Co-Primary Endpoints

AUSTIN, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage...

Biohaven Provides Update on Taldefgrobep Alfa Development Program for Spinal Muscular Atrophy and Obesity

NEW HAVEN, Conn., Nov. 25, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the...

Genentech Reports Update on Phase III SKYSCRAPER-01 Study Evaluating Tiragolumab Combined with Tecentriq

South San Francisco, CA -- November 25, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III...

Alpheus Medical Announces Positive Phase 1/2 Trial Results for the Treatment of Recurrent High-Grade Gliomas

CHANHASSEN, Minn., Nov. 24, 2024. Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of...

First Patient Dosed in Clinical Trial of ABI-110, a Groundbreaking Gene Therapy for Wet AMD Including PCV

HAYWARD, Calif., Nov. 21, 202. Avirmax Biopharma, Inc., a leader in the development of innovative gene therapies, today announced that the first patient has...

Mural Oncology Announces Publication Highlighting Promising Clinical Antitumor Activity Shown in its ARTISTRY-1 Clinical Trial of Nemvaleukin

WALTHAM, Mass. and DUBLIN, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel...

Melt Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for MELT-300, Its Lead Product Candidate for Opioid-Free, Sublingual Procedural Sedation in Patients Undergoing Cataract Surgery

NASHVILLE, Tenn.--(BUSINESS WIRE)--Nov. 20, 2024-- Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel...

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