Axsome FDA application accepted for 2027 target date

• Axsome Therapeutics announced that the FDA accepted its New Drug Application for AXS-12 to treat cataplexy in narcolepsy.
• The regulatory milestone advanced the treatment timeline by establishing a formal target action date of May 1, 2027.
• The company expects the drug to address the sudden loss of muscle tone experienced by most narcolepsy patients.

Axsome Therapeutics (NASDAQ:AXSM) announced the FDA accepted its New Drug Application for narcolepsy treatment AXS-12, setting a 2027 target date.

The regulatory acceptance advances a potential therapy for an estimated 70% of narcolepsy patients who experience sudden muscle tone loss.

The agency stated that it does not currently plan to hold an advisory committee meeting to discuss the application.

The investigational drug functions as a norepinephrine reuptake inhibitor designed to maintain patient muscle tone during periods of wakefulness.

The FDA previously granted Orphan Drug Designation to the treatment for its potential to address the serious neurological condition.

The company stated that narcolepsy remains a life-long condition that causes significant interference with cognitive, psychological, and social functioning.