Harmony Biosciences to Extend Pitolisant Exclusivity to 2044 with New Orexin Agonist

Harmony Biosciences Holdings reported positive bioequivalence results for its gastro-resistant pitolisant formulation and began a Phase 1 trial of an investigational orexin 2 receptor agonist for central disorders of hypersomnolence. This could extend pitolisant-related exclusivity towards 2044 and add a new mechanism in orexin agonism, deepening Harmony's sleep-disorder treatment portfolio. The pivotal bioequivalence success for pitolisant GR is a key near-term catalyst, but the longer-term risk of future generic competition or new therapies could pressure WAKIX-driven earnings.