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Aug 24, 2026
Japan's MHLW granted Orphan Drug Designation to three investigational therapies: gildeuretinol for Stargardt disease, QRX003 for Netherton Syndrome, and E2086 for narcolepsy, each offering potential 10-year market exclusivity.
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.
Jun 11, 2026
Takeda Pharmaceutical Company has announced updates on two ongoing neuroscience clinical trials: a Phase 2 study of TAK-360 for narcolepsy and a Phase 3 study of vortioxetine for major depressive disorder in Japanese teens. Both trials are randomized, triple-blind, and currently recruiting patients.
Apr 23, 2026
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Apr 19, 2026
Additional phase 2 data showed alixorexton sustained improvements in disease severity, cognition and fatigue in narcolepsy type 1 through weeks 12-13. The oral orexin 2 receptor agonist was generally well tolerated, with no serious treatment-emergent adverse events reported.
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.
Mar 09, 2026
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
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.
