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MAY 1 2027
UPCOMING · 214 DAYS TO PDUFA

Axsome Therapeutics — reboxetine $AXSM

for cataplexy in narcolepsy

NDA · Standard Review · Orphan

Accepted JUL 15 2026.

About

Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and sudden, brief episodes of muscle weakness or paralysis known as cataplexy, often triggered by strong emotions. AXS-12 is an oral drug that works by selectively increasing levels of norepinephrine and modulating dopamine in the brain. By boosting these key signaling chemicals, it could potentially help stabilize muscle control to reduce cataplexy attacks and improve alertness.

Pivotal trial

SYMPHONY Phase 3 completed NCT05059223

This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Source: ClinicalTrials.gov

Also in development