Narcolepsy
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for WAKIX/Pitolisant GR (H3 Antagonist) in Narcolepsy. The expected timing is based on the latest available company guidance and may change.
02/24/26:- Pitolisant GR NDA submission planned Q2 2026, with anticipated PDUFA approval decision in Q1 2027. 05/07/26:- Pitolisant GR NDA submission remains on track for Q2 2026; PDUFA decision still anticipated in Q1 2027. 08/04/26:- Pitolisant GR NDA accepted in July; target PDUFA April 1, 2027.
Verification
Confirm timing and program details against the company announcement or filing.