Axsome moves closer to FDA filing for narcolepsy treatment

Axsome Therapeutics said FDA feedback supports an NDA filing for AXS-12 to treat cataplexy in narcolepsy, with submission expected in January 2026. The drug, also known as reboxetine, has completed multiple efficacy trials and a long-term safety study and holds Orphan Drug Designation, which could grant seven years of US exclusivity if approved.