FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation

Reuters2025-12-31

FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation

Axsome Therapeutics Inc. 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, a treatment for agitation in Alzheimer’s disease. The FDA has granted the application Priority Review status, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. This designation is given to medicines that may offer significant improvements over existing treatments for serious conditions. AXS-05 previously received Breakthrough Therapy designation for this indication, and the supplemental NDA is supported by a comprehensive clinical development program, including four Phase 3 clinical trials.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Axsome Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9618516-en) on December 31, 2025, and is solely responsible for the information contained therein.

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