Xenon Pharmaceuticals Submits NDA For Azetukalner In Focal Seizures To FDA

• New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectively
• Enrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data readout expected Q1 2027
• The Company has voluntarily initiated a temporary pause of enrollment of new patients in ongoing psychiatry studies; patients currently enrolled in the ongoing studies remain active
• Conference call today at 4:30 pm ET

VANCOUVER, BC and BOSTON, MA, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need, today announced it has submitted a New Drug Application (NDA) for azetukalner in focal seizures (FS) to the U.S. Food and Drug Administration (FDA).

The NDA submission is based on positive clinical data from two global, randomized, double-blind, placebo-controlled trials for azetukalner in focal seizures, including the Phase 2b X-TOLE study and Phase 3 X-TOLE2 study. Across the two studies, treatment with all four doses of azetukalner demonstrated a statistically significant reduction from baseline in monthly seizure frequency compared with placebo, and azetukalner was generally well-tolerated with a consistent safety profile observed in both studies. These safety results are comparable with the long-term safety observed in the X-TOLE open label extension (OLE) study, with the entire epilepsy program generating more than 1,500 patient-years of safety and exposure data.