U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK)
Company Research
Source: Business Wire
This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment OptionsOveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and Address the Underlying Orexin Deficiency that Causes Narcolepsy Type 1The Prescription Drug User Fee Act (PDUFA) Target Action Date is the Third Quarter of this Calendar Year OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Takeda remains on track to potentially bring the fir
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TAK
Sec Filings
- 2/10/26 - Form 6-K
- 1/29/26 - Form 6-K
- 12/18/25 - Form 6-K
- TAK's page on the SEC website