EDS in Idiopathic Hypersomnia
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for WAKIX® (pitolisant) in EDS in Idiopathic Hypersomnia . The expected timing is based on the latest available company guidance and may change.
INTUNE Study. 5/25/23- Completed enrollment. 10/13/23- Announced topline data. 10/1/24- Reported new data at Investor Day. Submit sNDA in Q4 2024. 8/5/25- Initiate Ph3 registrational trial in Q4 2025. 11/04/25:- Pitolisant HD Phase 3 trial in idiopathic hypersomnia remains planned for Q4 2025; PDUFA decisions expected in 2028. 01/12/26:- ONSTRIDE 2 Ph3 HD pitolisant trial ongoing; topline data in 2027; PDUFA date anticipated in 2028. 02/24/26:- ONSTRIDE 2 Ph3 HD pitolisant trial in idiopathic hypersomnia ongoing; topline 2027; PDUFA anticipated 2028. 05/07/26:- ONSTRIDE 2 IH Ph3 HD pitolisant trial ongoing; topline 2027, PDUFA 2028; targeting sleep inertia labeling.
Verification
Confirm timing and program details against the company announcement or filing.