Harmony Biosciences Holdings Inc. Advances Orexin-2 Receptor Agonist BP1.15205 with EMA and FDA Regulatory Filings for First-in-Human Study Planned in 2H 2025

Reuters

06-11

Harmony Biosciences Holdings Inc. Advances Orexin-2 Receptor Agonist BP1.15205 with EMA and FDA Regulatory Filings for First-in-Human Study Planned in 2H 2025

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250611102843) on June 11, 2025, and is solely responsible for the information contained therein.

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