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

Nov 24, 2025 8:05 AM Eastern Standard Time Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation Share New Drug Application to be submitted in early 2026; target PDUFA in Q1 2027 Utility patent applications filed with potential exclusivity to 2044 PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant g ...