On Wednesday, the U.S. Food and Drug Administration (FDA) accepted Axsome Therapeutics Inc.’s (NASDAQ:AXSM) supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for Alzheimer’s disease agitation.The FDA granted the application Priority Review designation and set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.A Priority Review designation means the FDA’s goal is to take action on an application within 6 months, compared to 10 months under ...