FDA grants Priority Review to AXS-05 for Alzheimer's agitation; pre-NDA meeting supports AXS-12 narcolepsy filing

Axsome Therapeutics, Inc.

FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.
Pre-NDA meeting minutes confirm data package sufficient for AXS-12 (reboxetine) in narcolepsy cataplexy; NDA submission expected January 2026.
AXS-12 has Orphan Drug Designation for narcolepsy, potentially providing 7 years US exclusivity if approved.
AXS-05 previously received Breakthrough Therapy designation for Alzheimer's agitation (June 2020).

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