FDA Accepts Axsome NDA for AXS-12 Treatment of Narcolepsy Cataplexy

Axsome Therapeutics announced the FDA accepted its NDA for AXS-12 to treat cataplexy in narcolepsy, setting a PDUFA target date of May 1, 2027. This regulatory milestone advances the biopharmaceutical company's CNS pipeline and creates a path to market.