BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was desi

-DMD preclinical data support candidate declaration for GB703, a potential DMD gene therapy designed to broaden mutation coverage and improve muscle delivery -SMA1 preclinical data support the ongoing CHARISMA Phase 1/2 clinical trial for SMA1, which is advancing on schedule May 14, 2026 -- Gemma Biotherapeutics ("GEMMABio"), a clinical‑stage, global, genetic medicines company, today announced the presentation of preclinical data supporting candidate declaration for GB703, a novel, potential ge

May 14, 2026 -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical data on the Company's diabetes gene therapy drug candidate at the 2026 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. The collaborators presented preclinical data demonstrating that the diabetes gene ther

Tessera Therapeutics has created an experimental gene editing drug for sickle cell disease that could compete with commercial cell therapies but is delivered as an infusion — no complex cell engineering or chemotherapy preconditioning required. The closely watched and well-funded startup said that a single infusion of its experimental therapy edited the hemoglobin gene, which is mutated in the disease, in 85% of red blood cells in monkeys. That level of editing is almost triple the 30% threshol

May 12, 2026 -- Clearmind Medicine Inc. (Nasdaq: CMND) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced that two additional participants have been successfully dosed in the fourth cohort of its FDA-approved Phase I/IIa clinical trial evaluating CMND-100 (MEAI) for the treatment of moderate to s

May 12, 2026 -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from t

May 13, 2026 -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced topline clinical data on ABI-6250, an investigational oral hepatitis D virus (HDV) entry inhibitor, will be presented in a poster presentation at the European Association for the Study of the Liver (EASL) Congress taking place May 27-30, 2026, in Barcelona, Spain. “We are pleased to present additional Phase 1a data on ABI-6250 at

May 12, 2026 -- Virginia Cancer Specialists announced today its participation as a leading clinical trial site in a landmark study evaluating daraxonrasib, a first‑in‑class targeted oral therapy for patients with previously treated, advanced KRAS‑mutated pancreatic cancer. Results from the Phase 1/2 trial, published recently in The New England Journal of Medicine, demonstrated exceptional disease control in a cancer historically resistant to targeted treatment. Positive Phase 3 results reported

First Targeted Therapy Approved for NRG1+ Cholangiocarcinoma BIZENGRI Now Approved for Patients Harboring NRG1 Gene Fusions in Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, and Cholangiocarcinoma May 11, 2026 -- Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarci

Drug developers are racing to make gene therapies that could replace chronic GLP-1 injections and pills with a one-and-done treatment. Now, a company based just outside of Boston is poised to become the first to start a clinical trial of the potentially permanent approach. Fractyl Health has received clearance from European regulators to begin testing its gene therapy in the Netherlands, the company told Endpoints News. The treatment should allow people with type 2 diabetes to make more GLP-1 p