Business
Xenon Reports First Quarter 2025 Financial Results and Provides Business Update
– Phase 3 azetukalner X-TOLE2 FOS study patient recruitment expected to complete in the next few months with topline data anticipated in early 2026 – Phase 3

About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"– Phase 3 azetukalner X-TOLE2 FOS study patient recruitment expected to complete in the next few months with topline data anticipated in early 2026 – Phase 3 azetukalner X-NOVA3 MDD and Phase 3 BPD studies on track to initiate mid-year – Results from completed Mount Sinai IST in MDD confirm azetukalner drug activity as seen in X-NOVA – Phase 1 study in healthy volunteers initiated for follow-on Kv7 channel opener XEN1120 – IND filing and Phase 1 study start for XEN1701, lead Nav1.7 candidate, anticipated in Q3 2025 – Conference call at 4:30 pm ET today VANCOUVER, British Columbia and BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. “We continue to make steady progress across our Phase 3 epilepsy program, with patient recruitment into our X-TOLE2 study expected to complete in the next few months, positioning us to report topline results in early 2026. While this timing represents a modest shift from our prior guidance, we are encouraged that we are nearing the end of this important study which represents a significant milestone for Xenon, getting us one step closer to a potential first commercial product launch,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “Outside of epilepsy, we have made tremendous progress across our pipeline, including with azetukalner expansion into neuropsychiatry and significant advancements in our earlier-stage programs. Enrollment in our first Phase 3 MDD study, X-NOVA2, is progressing well and our second MDD study, X-NOVA3, along with our first Phase 3 study in bipolar depression are on track for initiation in the near term. In addition, there is great excitement and momentum across our early-stage programs, with the initiation of a Phase 1 study for our first follow-on Kv7 candidate, XEN1120, that we expect to study in pain, and we anticipate a regulatory filing followed by a Phase 1 study start for our lead Nav1.7 candidate, XEN1701, in the third quarter. It’s an incredibly exciting time for Xenon as we advance multiple late-stage development programs and continue to progress multiple ear...