The FDA accepted Axsome Therapeutics’ supplemental NDA for AXS-05 to treat agitation in Alzheimer’s disease and granted priority review, assigning a PDUFA date of April 30. The agency’s acceptance fast-tracks regulatory consideration for a disorder with limited pharmacologic options and an estimated market opportunity in the billions. Axsome reported a strong market reaction after the filing news. Priority review compresses the regulatory timeline and increases focus on the submitted efficacy and safety package; a positive outcome would expand AXS-05’s label beyond its current indications and alter the treatment mix for neuropsychiatric complications of dementia.