Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, a condition that affects up to three-quarters of patients, gaining access to a $1 billion-plus market and a clean label that counters the boxed warning of a competitor. The agency accepted the supplemental NDA under priority review on Dec. 31, 2025, and the breakthrough therapy approval, specifically for agitation associated with dementia due to Alzheimer’s disease, came on the April 30, 2026, PDUFA date. Read More
Seaport Therapeutics Inc. joined Nasdaq May 1, raising gross proceeds of $254.9 million, as its parent, Boston-based Puretech Health plc moved to exit the market, opting for a sole listing on the London Stock Exchange (LSE) in order to reduce its cost base and cut bureaucracy. Read More
Continuing biopharma’s IPO resurgence in 2026, Hemab Therapeutics Holdings Inc. priced an upsized offering of 16.75 million shares at $18 per share, the high end of its proposed price range, for gross proceeds of $301.5 million. Another $45 million could come if underwriters exercise their full overallotment. Read More
Hypervision Surgical Ltd. raised £17 million (US$23 million) in a series A financing round for its platform technology which combines spectral sensing with cloud-enabled AI analytics, to give surgeons real-time insights into tissue physiology during surgery that were previously impossible to see. Read More
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15. Read More
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC). Read More
A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis targeting chimera, or PROTAC, drug to reach the market. Read More
New hires and promotions in the biopharma and med-tech industries, including: Avita Medical, Halozyme, Johnson & Johnson, Microbot Medical, Proqr, Sanofi, Sonablate, Teleflex. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Agendia, Alector, Can-Fite, Edap TMS, Novo Nordisk, Renibus, Telix, TLC. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: AC Immune,Aptose, Astrazeneca, Bioreference Health, Cardioline, Cardios, Filament Health, Guardant, Maxxspine Innovative, Mintneuro, Motif, Nuvalent, Osartis, OSR, Pinetree, Red Light Holland, Takeda, Vaximm, Wellspect. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Curocell, Emergent, GSK, Newron, Orchard, Orchestra, OS, Prolong, Uniqure, Xbrane. Read More
