Posted by Michael Wonder on 01 Jan 2026
Axsome Therapeutics announces FDA acceptance and priority review of supplemental new drug application for AXS-05 for the treatment of Alzheimer’s disease agitation
31 December 2025 - FDA grants AXS-05 priority review designation and sets PDUFA action goal date of 30 April 2026.
Axsome Therapeutics today announced that the US FDA has accepted for filing the Company’s supplemental new drug application for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer’s disease agitation, and has granted the application priority review designation.
