FDA accepts Axsome's NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy; PDUFA May 1, 2027

Axsome Therapeutics, Inc.

FDA accepted for filing Axsome's New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy.
PDUFA target action date set for May 1, 2027.
FDA indicated it does not currently plan to hold an advisory committee meeting for the application.
Axsome Therapeutics (AXSM) announced the acceptance on July 15, 2026.

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