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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.

Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease

South San Francisco, CA -- July 20, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today topline results from the...

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following Three Deaths

July 18, 2025 -- The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb...

Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Relutrigine for the Treatment of Seizures Associated with SCN2A and SCN8A Developmental and Epileptic Encephalopathies

BOSTON, July 17, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic...

Johnson & Johnson Receives U.S. FDA Priority Review for TAR-200 NDA in High-Risk Non-Muscle Invasive Bladder Cancer

RARITAN, N.J., JULY 17, 2025 – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review...

Update on CARES Phase III Clinical Programme of Anselamimab in Light Chain Amyloidosis

16 July 2025 -- High-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme showed that anselamimab, a...

Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid

CAMBRIDGE, Mass.--(BUSINESS WIRE) Jul 15, 2025 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that...

Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA

SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the...

Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- July 15, 2025 -- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today...

Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

OSAKA, Japan and CAMBRIDGE, Massachusetts, July 14, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met...

Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill MK-8527

In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally RAHWAY, N.J.--(BUSINESS...

Baxdrostat Met the Primary and All Secondary Endpoints in BaxHTN Phase III Trial in Patients with Uncontrolled or Treatment Resistant Hypertension

14 July 2025 -- Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically...

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

NOVATO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration...

FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer

Los Angeles, July 9, 2025 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies...

Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine

CHATHAM, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today...

Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis

SAN FRANCISCO and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing...

Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma

OSLO, Norway, July 1, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers...

Amgen Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-line Gastric Cancer

THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line...

Breast Cancer Risk in Younger Women May Be Influenced by Hormone Therapy

June 30, 2025 -- Scientists at the National Institutes of Health (NIH) have found that two common types of hormone therapy may alter breast cancer risk in...

UCB Announces Positive Results from GEMZ Phase 3 Study of Fenfluramine in CDKL5 Deficiency Disorder

Brussels, Belgium – 27th June 2025 – UCB, a global biopharmaceutical company, today announced that the phase 3 study investigating the safety...

Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies

BOULDER, Colo., June 26, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today unveiled...

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2020
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2018
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2017
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2016
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