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.