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Xenon pauses phase 3 depression trials after psychosis events

Published

18 September 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

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Read at fiercebiotech.com →

◆ Verified

Fusion42 · 18 September 2026 · Fusion42 review

Xenon Pharmaceuticals has paused enrollment in phase 3 depression trials for azetukalner due to adverse events including psychosis, but plans to adjust dosing and continue. The company notified the FDA and expects to report data early next year despite the enrollment halt.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You face a new risk in depression drug trials where psychosis events can pause progress and alter timelines. Adjust your trial designs and patient communications to navigate evolving safety demands from regulators like the FDA.

◆ Coverage

1 source · 18 Sep 2026

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Biotechclinical-trialspsychiatrydrug-safetyfdadepression