(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 bioequivalent to the currently marketed 17.8 mg pitolisant tablet.
Topline results from a dosing-optimization study also showed that all patients were able to start treatment directly at the therapeutic 17.8 mg dose, removing the need for dose titration.
Pitolisant is marketed as Wakix for the treatment of narcolepsy.
With positive results from both studies, Harmony said it remains on track to submit a new drug application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027.
Harmony Biosciences shares were up 0.32% in pre-market trading at $34.42.
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