Narcolepsy
AXSMAxsome Therapeutics Inc.Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for AXS-12 (reboxetine) (NE reuptake inhibitor) in Narcolepsy. The expected timing is based on the latest available company guidance and may change.
SYMPHONY & ENCORE trials. 3/25/24- Reported topline data, met primary endpoint. 11/26/24- Reported ENCORE long-term data. 12/31/25:- Pre-NDA meeting minutes supports NDA. 2/23/26:- Company now plans to submit NDA in Q1 2026. 05/04/26:- NDA for AXS-12 for cataplexy in narcolepsy has been submitted; awaiting FDA decision on filing acceptance. 06/15/26:- ENCORE Ph3 open-label extension and randomized-withdrawal outcomes presented at SLEEP 2026. 07/15/26:- FDA accepted NDA for AXS-12; PDUFA action date May 1, 2027. No advisory committee planned.
Verification
Confirm timing and program details against the company announcement or filing.