“In the first quarter of 2026, we announced positive results from our X-TOLE2 study, which exceeded expectations and reinforced azetukalner’s significant potential to provide a new therapeutic option for FOS patients with uncontrolled seizures. The strong X-TOLE2 results have paved the way for us to submit an NDA to the FDA in the third quarter of 2026 and our commercial preparedness activities are well underway, supported by our strong balance sheet with cash runway into 2029,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “We remain enthusiastic about broadening the opportunity for azetukalner beyond FOS and are making good progress advancing multiple additional Phase 3 studies in epilepsy and neuropsychiatry indications. Additionally, we are looking forward to completing the first-in-human studies for our novel programs targeting NaV1.7 and KV7 in pain later this year.”
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