Axsome Therapeutics Wins US FDA Review for Narcolepsy Drug Application

Axsome Therapeutics (AXSM) said Wednesday the US Food and Drug Administration accepted its new drug application for AXS-12 to treat cataplexy, or muscle weakness, in narcolepsy. A target review date of May 1, 2027, has been set, and the FDA indicated it currently does not expect to convene an advisory committee meeting to evaluate the submission, the company said. Shares of the company were up nearly 1% in Wednesday premarket activity.