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BioSpace·2h ago·1 min read
save

Xenon shares plunge 23% after voluntary hold on psychiatry trials, despite filing NDA for epilepsy drug

Sep 18, 2026·read at BioSpace ↗RegulatoryNegative

Xenon Pharmaceuticals announced that its lead asset azetukalner (AZK) has been submitted to the FDA as a new drug application for focal onset seizures.

At the same time, the company disclosed a voluntary pause on its psychiatric studies of the same drug after several patients experienced psychosis, prompting a hold on those trials.

The news sent Xenon’s shares down about 23% in pre‑market trading, falling to $44.27 from $57.35 the previous close, despite the CEO’s optimism about the epilepsy opportunity valued at roughly $2 billion.

Analysts noted that while psychosis is a serious adverse event, similar issues have been seen with other psychiatric medicines and do not necessarily block the epilepsy program’s progress.

source

This writeup was produced by pharmadog from original reporting by BioSpace.

Original headline: “Xenon tumbles on voluntary psychiatry hold, but analysts confident in $2B epilepsy opportunity”

read at BioSpace ↗
1,189 words · retrieved 1h ago
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companies & drugs in this story

companies
Xenon Pharmaceuticals Inc.5JOHNSON & JOHNSONNeumora Therapeutics, Inc.Ultragenyx Pharmaceutical Inc.
drugs
XENON, XE-13319azetukalner7AUVELITYSERTRALINE HYDROCHLORIDEWELLBUTRINZoloft
topics
Epilepsy16Major Depression13Psychiatry & CNS8Neurology3ApprovalData ReadoutGene Therapy (AAV)OncologyRare Disease

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