PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ — Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug ...
New Data Shows Clinically Meaningful Sustained Efficacy of Pitolisant in Patients with Idiopathic Hypersomnia in Long-Term Extension Study; On Track to Submit sNDA in Q4 2024 Preliminary Data ...
PLYMOUTH MEETING, Pa., June 5, 2024 /PRNewswire/ -- Harmony Biosciences (HRMY) presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) ...
(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) said Monday that a pivotal bioequivalence (BE) study of its pitolisant gastro-resistant (GR) formulation showed that 17.8 mg of pitolisant GR is ...
PLYMOUTH MEETING, Pa., Feb. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its ...
PLYMOUTH MEETING, Pa., June 7, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative ...
WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in NarcolepsyOn Track to Extend the Pitolisant Franchise ...