Clinical Trial ResultsPreliminary open-label extension data from the Phase 3 ARGUS trial showed an approximate 50% reduction in median countable motor seizures for patients with Dravet syndrome, with a favorable safety profile.
Pipeline DevelopmentThe positive results position Harmony on track for a potential new drug application (NDA) filing expected in early 2026, with a target PDUFA (FDA action) date in 1Q27.
Product DifferentiationThe favorable safety profile of EPX-100 could differentiate it from current approved drugs like FINTEPLA, suggesting a potential competitive advantage.