FDA Grants Priority Review To Axsome's AXS-05 For Alzheimer's Agitation, Sets PDUFA Date For April 30, 2026

FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026

NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer's disease agitation, and has granted the application Priority Review designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.

Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. A Priority Review designation means the FDA's goal is to take action on an application within 6 months, compared to 10 months under standard review.