Xenon Pharmaceuticals Submits NDA For Azetukalner In Focal Seizures To FDA

Xenon Pharmaceuticals Inc. has submitted a New Drug Application (NDA) for azetukalner to the U.S. FDA for the treatment of focal seizures. This submission is supported by positive results from two clinical trials, showing a significant reduction in monthly seizure frequency compared to placebo. The company has also completed enrollment in the X-NOVA2 study for major depressive disorder (MDD) with approximately 360 patients, and expects topline data in Q1 2027. Additionally, Xenon has paused enrollment for new patients in ongoing psychiatry studies while current participants remain active.