Harmony Biosciences Holdings Inc. has announced the ongoing regulatory review of their investigational drug BP1.15205, a highly potent orexin 2 receptor agonist, designed to treat narcolepsy and other central disorders of hypersomnolence. The company is in the process of completing an Investigational Medicinal Product Dossier (IMPD) application with the European Medicines Agency $(EMA)$ and plans to file an Investigational New Drug $(IND.AU)$ application with the U.S. Food and Drug Administration (FDA). A first-in-human study is slated to begin in the second half of 2025, with topline clinical data expected in 2026. These regulatory steps mark a significant advancement in Harmony Biosciences' commitment to expanding their sleep-wake franchise and potentially offering a novel treatment for individuals affected by hypersomnolence disorders.
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