Harmony Biosciences To Present New Data From Phase 3 Trial Of EPX-100 In Dravet Syndrome Next Week

Harmony Biosciences

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(RTTNews) - Harmony Biosciences Holdings Inc. (HRMY) is set to highlight new open-label extension data from its ongoing ARGUS trial at the American Epilepsy Society Annual Meeting on December 8, 2025.

ARGUS is a phase 3 trial evaluating the efficacy and safety of the company's lead drug candidate EPX-100 as an adjunctive therapy in children and adult participants with Dravet syndrome.

The study includes a 4-week Observational Period, a 16-week Double-Blind (DB) Period and an Open-Label Extension (OLE) Period for up to 156 weeks.

EPX-100, originally developed by Epygenix Therapeutics, became part of Harmony Biosciences' pipeline when it acquired Epygenix in April 2024.

The company expects to report topline data from the phase 3 ARGUS trial of EPX-100 in Dravet syndrome in 2026.

Dravet syndrome is a rare, severe form of epilepsy that begins in infancy and is characterised by prolonged seizures, intellectual disability, and a risk of sudden unexpected death. The estimated incidence rate of Dravet syndrome is 1:15,700.

HRMY has traded in a range of $25.52 to $40.93 in the last 1 year. The stock closed Tuesday's trading at $36.01, up 1.41 %.