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News  ›  GlobeNewswire Inc.

Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

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Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

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.

Insights
MERpK   neutral

The announcement indicates a strategic increase in financial instruments without explicit positive or negative implications, representing a neutral market movement


AXSM   positive

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.