Xenon Pharmaceuticals announced Phase 3 X‑Tole2 results showing azetukalner reduced focal‑onset seizure frequency by 53.2% at the 25 mg dose versus placebo—an effect the company characterized as exceeding expectations. Xenon said it will file for FDA approval in the third quarter and highlighted a favorable tolerability profile. Investors reacted strongly: the stock jumped more than 40% after the readout. Company executives and analysts cited the magnitude of placebo‑adjusted efficacy and an attractive safety profile—particularly at the lower 15 mg dose—as positioning azetukalner for rapid uptake if regulators approve. Xenon plans an NDA submission targeting U.S. approval later this year.
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