<p>The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Takeda Pharmaceutical Co. Ltd.’s investigational therapy oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1), and has granted the application Priority Review status. Oveporexton is an oral orexin receptor 2 (OX2R)-selective agonist intended to address orexin deficiency, the underlying cause of NT1. The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date for the third quarter of the current calendar year. Oveporexton has previously received Breakthrough Therapy designation from the FDA and the Center for Drug Evaluation of China’s National Medical Products Administration, as well as Sakigake designation from the Japanese Ministry of Health, Labour and Welfare. 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. Takeda Pharmaceutical Co. Ltd. published the original content used to generate this news brief on February 10, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here</p>

FDA Accepts Takeda's Oveporexton Application for Priority Review in Narcolepsy Type 1