Clinical Trial SuccessPreliminary 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.
Earnings GrowthHarmony raised full-year 2025 revenue guidance to $845–$865 million, reflecting confidence in the underlying demand trajectory.
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.