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Aug 06, 2026
FDA approved Orzeyful (oveporexton), the first drug to target the underlying loss of orexin signaling in narcolepsy type 1. In two 12-week trials, the twice-daily tablet improved wakefulness and reduced cataplexy versus placebo.
Jul 11, 2026
Takeda reported positive ENTYVIO pediatric data, secured FDA Priority Review for oveporexton, and expanded AI drug discovery. Shares trade at ¥5,609; analyst fair value is about ¥5,263.
Mar 20, 2026
The FDA accepted Takeda's new drug application for oveporexton, an investigational orexin 2 receptor agonist for narcolepsy type 1, and granted priority review with a PDUFA action date in Q3 2026.
May 03, 2025
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
