Nov 24 2025
Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation

PLYMOUTH MEETING, Pa.–(BUSINESS WIRE)–Nov. 24, 2025– Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive findings from both the pivotal BE and dosing optimization studies, Harmony is on track to submit a New Drug Application (NDA) for pitolisant GR in early 2026, targeting a PDUFA date in Q1 2027. With utility patent applications filed for pitolisant GR with potential exclusivity to 2044, Harmony is well positioned to extend the pitolisant franchise into the mid-2040s.

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