Axsome Therapeutics (NASDAQ:AXSM) is poised to file for U.S. regulatory approval of its narcolepsy treatment, AXS-12, following a successful pre-New Drug Application (NDA) meeting with the Food and Drug Administration.
The company announced Wednesday that formal meeting minutes indicate the FDA is satisfied with the current regulatory data package, paving the way for a formal submission in January 2026.
The filing targets the treatment of cataplexy, a sudden, debilitating loss of muscle tone triggered by emotion that affects roughly 70% of the narcolepsy population.
AXS-12 (reboxetine) is a highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator.
The upcoming NDA is backed by a robust clinical suite, including the Phase 3 SYMPHONY and ENCORE trials.
In the SYMPHONY study, patients treated with AXS-12 saw an 83% reduction in weekly cataplexy attacks, compared to 66% for placebo, with significant improvements in excessive daytime sleepiness (EDS) and cognitive function.
The drug holds FDA Orphan Drug Designation, a status that grants Axsome seven years of market exclusivity upon approval and a waiver for millions in regulatory user fees.
If accepted and approved, AXS-12 would join Axsome’s growing commercial portfolio, which includes the antidepressant Auvelity and the wake-promoting agent Sunosi.