Takeda’s oral orexin-2 receptor agonist Orzeyful (oveporexton) received FDA approval for narcolepsy type 1, with the company positioning the drug as the first therapy designed to address the underlying cause in adults. The approval follows data from two large clinical trials showing improved wakefulness and reduced cataplexy with a favorable overall safety profile. The FDA clearance comes after regulatory steps elsewhere, including earlier approval in China. After FDA scheduling review completes, Takeda will be able to launch more broadly. In a related cluster of neurology-focused pipeline and investment activity, the market continues to prioritize mechanistically novel CNS drugs even as reimbursement and long-term outcomes remain key decision points.