Axsome Therapeutics secures FDA priority review for Alzheimer’s agitation treatment AXS-05
Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AXS-05 seeking approval for the treatment of agitation associated with Alzheimer’s disease, and has granted Priority Review designation to the filing. The regulatory body has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026, underlining the importance of this potential new therapy in an area of high unmet need.




















