Harmony Biosciences (HRMY) announced results from its bioequivalence study evaluating pitolisant gastro-resistant formulation. With findings from both the pivotal BE and dosing optimization studies, ...
In November 2025, Harmony Biosciences reported positive pivotal bioequivalence results for its gastro-resistant pitolisant formulation and began a Phase 1 trial of BP1.15205, an investigational orexin ...
(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 ...
Credit: Getty Images. Harmony Biosciences announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for pitolisant for the treatment of ...
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration ...
Prescription Drug User Fee Act date is June 21, 2024 About NarcolepsyNarcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 ...
PLYMOUTH MEETING, Pa., Oct. 13, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients ...
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