FDA grants Axsome’s AXS-05 sNDA priority review designation

2 January 2026

The US Food and Drug Administration (FDA) has accepted for filing Axsome Therapeutics’ (Nasdaq: AXSM) supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer’s disease agitation.

At the same time the agency granted the application Priority Review designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. Axsome’s shares rose 23% to $183.01 on the news released on December 31.

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