Metis Techbio Co. Ltd. is seeking a potential HK$2.11 billion (US$270 million) raise through a stock sale May 13, marking the largest biotech raise on the Hong Kong Stock Exchange this year to date. Hangzhou, China-based Metis is an AI-based nanoparticle drug formulation and delivery-focused company. Synthetic lethality-based cancer drugmaker Impact Therapeutics Inc., of Shanghai, plans to debut on the same day with a US$117 million IPO.
Rigel Pharmaceuticals Inc. CEO Raul Rodriguez said breast cancer therapy Veppanu (vepdegestrant) could become his firm’s “largest product with the current label,” and other opportunities with the drug are lined up behind, albeit “still a bit early.”
Raising $279 million in an IPO and another $25 million in a concurrent private placement, Odyssey Therapeutics Inc. is advancing its lead phase II asset, OD-001, in ulcerative colitis, with plans to bring its SLC15A4 program into the clinic for lupus.
Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash deal worth $4.1 billion. The acquisition gives Angelini ownership of three marketed drugs for treating epilepsy and neuromuscular diseases that had combined sales of $589 million in 2025, a 19.8% increase over 2024.
In its first substantial M&A transaction since 2021, Bayer AG is buying Perfuse Therapeutics Inc., a firm that has operated quietly, though it reported positive midstage data last year for PER-001, an endothelin antagonist, in glaucoma and diabetic retinopathy.
As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort.
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.
The memory of Merck & Co. Inc.’s $10 billion takeover last year of inhaled respiratory drug specialist Verona Pharma plc may not have been far from the minds of Wall Street speculators as Avalyn Pharma Inc. priced its IPO, selling about 16.6 million shares at the high end of the targeted range, or $18 each, to reap about $300 million. The stock (NASDAQ:AVLN) came out of the gate strong on the first day of trading and closed April 30 at $29.49, up $11.49, or 64%.
Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.