Omeros Corporation (NASDAQ:OMER) said the U.S. Food and Drug Administration approved YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, marking the first authorized therapy for the life-threatening condition.
Repare Therapeutics (NASDAQ:RPTX) has entered into a definitive asset purchase agreement to sell its polymerase theta (Polθ) ATPase inhibitor, RP-3467, to Gilead Sciences (NASDAQ:GILD) for up to $30 million.
Edgewise Therapeutics (NASDAQ:EWTX) said it has completed Parts B and C of the CIRRUS-HCM study and reported favorable interim safety data from Part D for EDG-7500, its selective oral cardiac sarcomere modulator being developed for obstructive and nonobstructive hypertrophic cardiomyopathy
Agios Pharmaceuticals (NASDAQ:AGIO) announced today that the U.S. Food and Drug Administration (FDA) has approved AQVESME™ (mitapivat) for the treatment of anemia in adults with alpha- or beta-thalassemia.
Sanofi (NASDAQ:SNY) has reached a definitive agreement to acquire vaccine specialist Dynavax Technologies (NASDAQ:DVAX) for $15.50 per share in cash, the companies announced Wednesday.
Quantum BioPharma (NASDAQ:QNTM) has successfully completed oral dosing in both its 180-day repeated-dose toxicity and toxicokinetic studies for Lucid-21-302, its lead candidate for the treatment of multiple sclerosis (MS).
Agenus (NASDAQ:AGEN) has published peer-reviewed results from the ovarian cancer cohort of its Phase 1b trial in The Journal for ImmunoTherapy of Cancer (JITC), highlighting a potential breakthrough for a patient population with historically limited options.
Coya Therapeutics, (NASDAQ: COYA) announced today that Health Canada has accepted its Clinical Trial Application (CTA) for COYA 302, a potential breakthrough combination biologic for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Dyne Therapeutics (NASDAQ:DYN) announced the appointment of Vikram Karnani to its Board of Directors on December 23, 2025.
Zai Lab Limited (NASDAQ:ZLAB) received marketing authorization from China’s National Medical Products Administration (NMPA) for Cobenfy, a groundbreaking treatment for schizophrenia in adults.
Trinity Biotech (NASDAQ:TRIB) shares are in focus after the diagnostics specialist reported a return to positive adjusted EBITDA and secured a major 9 million-unit order for its flagship HIV screening product.
Invivyd (NASDAQ:IVVD) received U.S. Food and Drug Administration Fast Track designation for VYD2311, an investigational monoclonal antibody designed as a long-acting, intramuscular alternative to traditional vaccines for individuals at high risk of severe COVID-19.
