Business
Xenon Reports Q4 and Full Year 2025 Financial Results and Provides Business Update
Phase 3 X-TOLE2 topline data for azetukalner in FOS expected first half of March 2026Five additional Phase 3 studies of azetukalner continue to enroll in
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"Phase 3 X-TOLE2 topline data for azetukalner in FOS expected first half of March 2026Five additional Phase 3 studies of azetukalner continue to enroll in epilepsy and neuropsychiatry indications with Phase 3 X-NOVA2 MDD topline data expected in H1 2027 Data from two Phase 1 studies of novel NaV1.7 (XEN1701) and KV7 (XEN1120) candidates expected in 2026 to support Phase 2 proof-of-concept studies in pain Pro forma cash of $716 million including recent ATM sales extends cash runway into second half of 2027Xenon’s next investor call to be held for X-TOLE2 topline data readout VANCOUVER, British Columbia and BOSTON, Feb. 26, 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 reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update. “2025 marked a period of significant momentum and strong execution across multiple Phase 3 clinical trials of azetukalner in epilepsy and neuropsychiatry, as well as our early-stage pipeline that includes two novel ion channel modulators for pain,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “We’re looking forward to several upcoming milestones, starting with reporting topline data for our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures in the first half of March, followed by an anticipated NDA submission in the second half of this year.” Business Highlights and Anticipated Milestones Azetukalner Clinical Development Azetukalner, a novel, potent KV7 potassium channel opener, represents the most advanced, clinically-validated potassium channel modulator in late-stage clinical development for the treatment of multiple indications, including two in epilepsy – focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS) – as well as neuropsychiatric disorders, including major depressive disorder (MDD) and bipolar depression (BPD). Epilepsy Programs Topline data from the Phase 3 X-TOLE2 study of azetukalner in FOS are on track for the first half of March 2026.Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States. Xeno...