Axsome Therapeutics Says FDA Accepts NDA For AXS-12 For Treatment Of Cataplexy In Narcolepsy; PDUFA Target Action Date Set May 1, 2027

Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc.

AXSM

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Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.