Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
12/31/2025 07:00 AM • Axsome Therapeutics announced that the FDA has accepted and granted Priority Review designation to its supplemental NDA for AXS-05 for treating Alzheimer's disease agitation, with a PDUFA target action date of April 30, 2026. The drug addresses a significant unmet medical need, as up to 76% of Alzheimer's patients experience agitation. AXS-05 previously received Breakthrough Therapy designation in June 2020.
AXSM - The company received FDA Priority Review designation for AXS-05, which accelerates the review timeline from 10 to 6 months. This represents significant regulatory progress for a drug addressing a major unmet medical need affecting 76% of Alzheimer's patients. The Priority Review status indicates FDA recognition of the drug's potential to provide substantial improvements over existing treatments.
Investing.com • Thomas Hughes