AXS-12: cataplexy FDA decision
Axsome announced FDA acceptance of the AXS-12 NDA for cataplexy in narcolepsy with a May 1, 2027 target. Its August SEC-filed update retains that target. This is reboxetine, distinct from AUVELITY and from AXS-14 in fibromyalgia.
Axsome Therapeutics / AXSMDrug catalystsRegulatory decisionTarget: 2027-05-01
What matters
Follow the exact application, indication and requested label. An FDA decision concerns the drug program, while the company’s stock also reflects its other assets and business.
- The indication is cataplexy in narcolepsy, not every narcolepsy symptom.
- An FDA plan not to convene an advisory committee is neither approval nor a guarantee of the target date.
Primary evidence
FDA target 2027-05-01 — not a guaranteed decision date
Axsome · SEC-filed FDA acceptance announcementPublished 2026-07-15
Axsome · second-quarter regulatory updatePublished 2026-08-10
Potential outcome market
Will FDA approve AXS-12 (reboxetine) for cataplexy in narcolepsy by a separately fixed evidence cutoff?
This event is research, not a listed market. A market needs a precise question, resolution rules and liquidity before trading opens.