FDA Accepts Axsome Therapeutics' Application for AXS-12

By Greg Peters • Wednesday, July 15 13:02 • Permanent Link

Axsome Therapeutics said the FDA has accepted for filing its new drug application for AXS-12, a treatment for cataplexy in narcolepsy, and set a PDUFA target action date of May 1, 2027.

The filing marks a new regulatory step for the drug, which is being developed as a selective norepinephrine reuptake inhibitor and cortical dopamine modulator. Axsome said the FDA does not currently plan to hold an advisory committee meeting on the application.

Narcolepsy affects an estimated 70% of patients with cataplexy, according to the company’s release. Cataplexy is described as a sudden loss of muscle tone while awake, often triggered by emotion. Axsome said narcolepsy is associated with a 1.5-fold higher mortality rate and can raise risks tied to work and driving.

AXS-12 is not yet approved by the FDA. The drug has previously received orphan drug designation for narcolepsy. Following these announcements, the company's shares moved -1.81%, and are now trading at a price of $231.01. Check out the company's full 8-K submission here.

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