Dravet syndrome
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for EPX-100 (clemizole hydrochloride) in Dravet syndrome. The expected timing is based on the latest available company guidance and may change.
ARGUS Ph3 trial. 4/30/24 Asset from Epygenix Therapeutics acquisition. 8/5/25- Enrollment ongoing. Topline data in 2026. 12/2/25– Present new OLE data via poster at AES’25 on December 8,2025. 11/04/25:- ARGUS Phase 3 Dravet enrollment ongoing; topline data expected 2026; open-label extension data planned for December 2025 AES. 12/08/25:- ARGUS OLE shows ~50% median seizure reduction; EPX-100 well tolerated; topline Ph3 data expected 2026. 01/12/26:- ARGUS Ph3 Dravet enrollment ongoing; topline data now anticipated in H1 2027 after OLE presentation at AES 2025. 02/24/26:- ARGUS Ph3 Dravet enrollment ongoing; topline data anticipated H1 2027; OLE seizure reduction data previously presented December 2025. 04/16/26:- ARGUS OLE encore data to be presented at AAN 2026 on April 22, 2026. 05/07/26:- ARGUS Ph3 Dravet enrollment ongoing; OLE encore AAN April 2026 showed meaningful seizure reduction; topline H1 2027; PDUFA 2028.
Verification
Confirm timing and program details against the company announcement or filing.