Unicycive Therapeutics (NASDAQ:UNCY) said it has resubmitted its 505(b)(2) New Drug Application to the U.S. Food and Drug Administration for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients receiving dialysis.
Bluejay Diagnostics (NASDAQ:BJDX) said it has completed commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6) for its Symphony™ cartridge program, marking a development milestone for the diagnostic platform.
HUTCHMED (NASDAQ:HCM) announced Monday that the China National Medical Products Administration (NMPA) has accepted its New Drug Application for fanregratinib and granted it priority review status.
Cango (NYSE:CANG) entered into a definitive investment agreement on Dec. 29, 2025, with Enduring Wealth Capital Limited (EWCL) for the private placement of 7 million Class B ordinary shares.
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).
