The FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS-05 (Auvelity) to treat agitation in Alzheimer’s disease and granted the filing priority review, assigning an April 30 PDUFA date. The agency’s action accelerates regulatory timelines for a supplemental indication that analysts value as a greater-than-$1 billion commercial opportunity. Axsome’s regulatory submission rests on clinical data the company provided to support symptomatic benefit in patients with Alzheimer’s-related agitation. Priority review signals the FDA sees potential to address an unmet medical need in neuropsychiatric complications of dementia. Market participants will monitor the agency’s review for any requests for additional efficacy evidence or safety clarifications; a favorable decision would expand Auvelity’s label and reshape commercial positioning in neurodegenerative care pathways.