Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy
Axsome Therapeutics announced the FDA has accepted its New Drug Application for AXS-12, a treatment for cataplexy in narcolepsy, with a target action date under the PDUFA of May 1, 2027. The FDA currently does not plan an advisory committee meeting for this application. AXS-12 is a norepinephrine reuptake inhibitor aimed at improving wakefulness an…