Xenon Pharmaceuticals says it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for azetukalner in focal seizures. The company also provides an update on its psychiatry program, including ongoing enrollment and study status across multiple clinical trials.
For its epilepsy-related studies, Xenon states that patients continue to enroll in its focal seizure and related convulsive seizure programs, including X-TOLE3 and X-ACKT. On the psychiatry side, the company reports that enrollment in its X-NOVA2 study for major depressive disorder (MDD) is complete, with approximately 360 total patients. Xenon expects topline data from X-NOVA2 in Q1 2027. The company also notes it has voluntarily initiated a temporary pause of enrollment in at least one program segment, indicating ongoing adjustments to trial operations while it advances the NDA submission and reviews progress within its pipeline.
Across the outlets, the focus is on the same core developments: the azetukalner NDA submission to the FDA and continued activity and timelines within Xenon’s psychiatry pipeline, with specific study names and expected reporting dates cited to contextualize near-term milestones.
