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azetukalner

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Xenon Pharmaceuticals' azetukalner program faces heightened attention after a psychiatry trial enrollment pause overshadowed the drug's FDA filing for focal seizures. Representative image.
Pharma & Biotech

Why Xenon Pharmaceuticals stock crashed 31% even after filing azetukalner FDA application

Xenon Pharmaceuticals shares suffered their biggest recent sell-off after the company paused new enrollment in late-stage depression studies over neuropsychiatric adverse events, overshadowing an important FDA filing for azetukalner in focal seizures.

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Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures while separately evaluating neuropsychiatric adverse events in its depression programmes. Representative image.
Features & Analysis

Azetukalner’s epilepsy NDA is backed by 1,500 patient-years. Do psychiatric adverse events change the regulatory equation?

Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures after strong Phase 3 efficacy and more than 1,500 patient-years of epilepsy exposure. On the same day, the company paused new enrollment in psychiatry studies after neuropsychiatric adverse events emerged, creating a difficult question over how regulators and investors should interpret safety signals that

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