The Plymouth Meeting, Pa., company termed the FDA's refusal to file a short-term setback and said its long-term strategy for pitolisant in idiopathic hypersomnia is on track with its focus on a ...

Harmony Biosciences received an FDA Refusal to File letter for pitolisant in idiopathic hypersomnia but plans a Phase 3 trial in Q4 2025. Q4 net product revenue reached $201M, surpassing estimates ...