XENE: FDA NDA submitted for azetukalner in epilepsy; psychiatry studies paused for dosing adjustments

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Azetukalner's NDA for focal seizures was submitted to the FDA, supported by strong efficacy and safety data from pivotal trials. Enrollment in psychiatry studies is temporarily paused to adjust dosing after rare, mostly mild neuropsychiatric events, with top-line MDD results expected in Q1 2027.

Based on [Xenon Pharmaceuticals Inc. [XENE] FDA announcement Audio Transcript — Sep. 17 2026](https://www.tradingview.com/symbols/NASDAQ-XENE/documents/)

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