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 U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors.
The U.S. Department of Health and Human Services (HHS) has appealed a recent federal ruling that put on hold several changes to the childhood vaccine schedule and the Advisory Committee on Immunization Practices as reconstituted by HHS Secretary Robert Kennedy.
Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth more than $2 billion for Huahui Health Ltd., the developer of the trispecific antibody.
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.
Dermatology specialist Leo Pharma A/S is moving into gene therapy with the $50 million acquisition of Replay Holdings LLC, a seed-stage company that is developing high capacity herpes simplex virus vectors to treat rare inherited diseases.
More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties.
Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
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