HRMY's EPX-100 Advances Into New Data Milestone: Phase 3 Extension Results Ready For AES Presentation

Harmony Biosciences Holdings Inc. (HRMY) is preparing to unveil the latest extension phase findings from its ongoing ARGUS trial, a phase 3 clinical study evaluating EPX-100 as an add-on treatment for Dravet syndrome patients. The company will feature these new open-label extension results at the American Epilepsy Society Annual Meeting scheduled for December 8, 2025.

The ARGUS trial represents a comprehensive three-stage study design encompassing a 4-week observation baseline, followed by a 16-week double-blind treatment period, and an extended open-label phase lasting up to 156 weeks. This multi-phase extension approach allows researchers to evaluate both the short-term efficacy and the long-term safety profile of EPX-100 in both pediatric and adult patient populations with this challenging neurological condition.

EPX-100 entered Harmony Biosciences’ development pipeline through the company’s acquisition of Epygenix Therapeutics in April 2024, bringing with it this promising lead candidate. Harmony expects to release the complete topline data package from the entire phase 3 ARGUS program by 2026, providing a fuller picture of EPX-100’s therapeutic potential.

Dravet syndrome represents one of the most severe epilepsy forms, typically manifesting during early infancy and characterized by frequent prolonged seizures, developmental delays, and the serious risk of sudden unexpected nocturnal death in epilepsy (SUDEP). The condition affects approximately 1 in 15,700 individuals, making it a rare but devastating neurological disorder.

From a market perspective, HRMY has demonstrated notable trading range over the past twelve months, fluctuating between $25.52 and $40.93 per share. The stock concluded Tuesday’s session at $36.01, reflecting a 1.41% daily gain.