Axsome's New Drug Application for Narcolepsy Treatment Accepted by FDA
By Robb M. Stewart
Axsome Therapeutics' new drug application for AXS-12 for the treatment of cataplexy in narcolepsy has been accepted by the U.S. Food and Drug Administration.
The biopharmaceutical company said Wednesday the FDA set a Prescription Drug User Fee Act target action date of May 1, 2027, and indicated that it doesn't currently plan to hold an advisory committee meeting to discuss the application.
Cataplexy is seen in an estimated 70% of narcolepsy patients. It refers to a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress or excitement.
Narcolepsy is a neurological disorder that disrupts the brain's ability to regulate sleep-wake cycles.
AXS-12 has been granted FDA orphan drug designation for the treatment of narcolepsy but hasn't been approved by the FDA.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
July 15, 2026 07:46 ET (11:46 GMT)
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