Xenon Submits Azetukalner NDA While Pausing Some Psychiatry Studies
Xenon Pharmaceuticals has filed its first new drug application for azetukalner to treat focal-onset seizures, backed by the X-TOLE and X-TOLE2 trials. The company paused parts of its late-stage psychiatry program to assess dose-escalation changes aimed at improving tolerability. Xenon expects FDA review to take about a year, with possible DEA scheduling adding roughly three months after approval.
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