Harmony to Begin Phase 3 Study of Pitolisant for Prader-Willi Syndrome
Harmony Biosciences Holdings Inc has completed an end-of-phase 2 meeting with the US Food and Drug Administration (FDA) regarding its clinical development plan evaluating pitolisant as a potential treatment for excessive daytime sleepiness in patients ages 6 and older with Prader-Willi syndrome. Harmony plans to initiate a phase 3 registrational study in the fourth quarter…