Harmony Biosciences Holdings, Inc.

The company is a neuroscience company focused on rare neurological diseases, with a portfolio covering sleep/wake, rare epilepsy, and neurobehavioral conditions. Its lead product is WAKIX® (pitolisant), a therapy that enhances histamine signaling in the brain by binding to H3 receptors. The company acquired exclusive commercialization rights for pitolisant from Bioprojet Société Civile de Recherche ("Bioprojet") in July 2017. WAKIX was initially approved by the FDA in 2019 for excessive daytime sleepiness ("EDS") in adult narcolepsy patients, followed by approvals for cataplexy in adult patients in 2020, EDS in pediatric patients six years and older in 2024, and cataplexy in pediatric patients six years and older in 2026. WAKIX is the only FDA-approved narcolepsy treatment not scheduled as a controlled substance by the U.S. Drug Enforcement Administration ("DEA"). The company is also exploring pitolisant in late-stage clinical programs for idiopathic hypersomnia ("IH"), Prader-Willi syndrome ("PWS"), and myotonic dystrophy type 1 ("DM1"). In July 2022, the company obtained exclusive rights from Bioprojet to manufacture, develop, and commercialize next-generation pitolisant-based products in the United States and Latin America, including pitolisant Gastro-Resistant ("Pitolisant GR") and pitolisant High-Dose ("Pitolisant HD"), both currently in clinical development. In April 2024, the company expanded into orexin science through a sublicense agreement with Bioprojet for BP1.15205, an orexin 2 receptor agonist in preclinical development for narcolepsy and other potential indications.