Narcolepsy
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for WAKIX/Pitolisant HD (H3 Antagonist) in Narcolepsy. The expected timing is based on the latest available company guidance and may change.
11/04/25:- Pitolisant HD IND submitted; narcolepsy Ph3 registrational trial planned Q4 2025; target PDUFA date in 2028. 01/12/26:- ONSTRIDE 1 Ph3 pitolisant HD narcolepsy trial ongoing; topline data in 2027; PDUFA anticipated in 2028. 02/24/26:- ONSTRIDE 1 Ph3 HD pitolisant narcolepsy trial ongoing; topline data 2027; PDUFA approval decision anticipated 2028. 05/07/26:- ONSTRIDE 1 Ph3 HD pitolisant narcolepsy trial ongoing; topline 2027; PDUFA 2028; targeting fatigue labeling.
Verification
Confirm timing and program details against the company announcement or filing.