FDA gives priority review to AXS‑05 – Axsome targets Alzheimer’s agitation

The U.S. FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS‑05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting a PDUFA goal date of April 30. The agency’s acceptance follows submission of pivotal data arguing clinical benefit in a high‑unmet‑need population. Axsome’s shares rose sharply on the news, reflecting the market’s view of a potential blockbuster opportunity in dementia behavioral symptoms. Priority review accelerates the regulatory timeline and signals the agency sees potential for significant patient benefit, but the company will still need to demonstrate a favorable risk‑benefit profile in an older, comorbid population.