Xenon Phase 3 X-TOLE2 azetukalner meets primary endpoint; NDA submission Q3 2026

Xenon Pharmaceuticals Inc.

Primary endpoint MPC: 25mg -53.2% vs placebo -10.4% (p<0.000000000006); placebo-adjusted -42.7%, outperforming Phase 2b.
Key secondary RR50: 54.8% (25mg) vs 20.8% placebo (p=0.00000008).
Safety consistent: most common TEAEs dizziness (20.5%), headache (8.8%), somnolence (8.8%), fatigue (7.6%).
NDA submission to FDA planned Q3 2026 for focal onset seizures.
Data to be presented as Late Breaking Science at AAN Annual Meeting in April 2026.

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