Axsome Therapeutics said the FDA has accepted its new drug application for AXS-12, its narcolepsy candidate for cataplexy, and set a PDUFA target action date of May 1, 2027.
The company did not disclose any new financial figures in the release, but it did add two regulatory milestones: the application has been accepted for filing, and the FDA does not currently plan to convene an advisory committee meeting.
AXS-12, also known as reboxetine, is being developed as a treatment for cataplexy in narcolepsy. The company said the drug has received FDA orphan drug designation for narcolepsy.
Narcolepsy affects sleep-wake regulation and is commonly marked by excessive daytime sleepiness and cataplexy. Axsome said cataplexy is seen in an estimated 70% of narcolepsy patients. The company also said the condition is associated with a 1.5-fold higher mortality rate.
Axsome’s neuroscience portfolio already includes FDA-approved treatments for major depressive disorder, agitation linked to dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine. Following these announcements, the company's shares moved 0.5%, and are now trading at a price of $236.44. For more information, read the company's full 8-K submission here.
