Lennox-Gastaut Syndrome (LGS)
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for EPX-100 (clemizole hydrochloride) in Lennox-Gastaut Syndrome (LGS). The expected timing is based on the latest available company guidance and may change.
EPX 100-003 trial. Poster presentation at IEC '25. Trial currently enrolling. 11/04/25:- LIGHTHOUSE Phase 3 Lennox-Gastaut trial enrollment ongoing; topline data anticipated in 2026. 01/12/26:- LIGHTHOUSE Ph3 LGS enrollment ongoing; topline data now anticipated in H1 2027. 02/24/26:- LIGHTHOUSE Ph3 LGS enrollment ongoing; topline data anticipated H1 2027 for EPX-100 clemizole hydrochloride. 05/07/26:- LIGHTHOUSE Ph3 LGS enrollment ongoing across regions; topline H1 2027; potential FDA PDUFA decision in 2028.
Verification
Confirm timing and program details against the company announcement or filing.