Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on ...
Xenon said the pause was a precaution after side effects in psychiatry studies, and shares fell more than 20% in after-hours trading.
- Xenon Pharmaceuticals on Thursday paused enrolling new patients in clinical studies testing its experimental drug for major depression and bipolar disorder following reports of mental and nervous system-related side effects.
- The voluntary pause follows reports of confusion, speech difficulties, and motor coordination issues, with company executives reporting a 'very small number' of cases classified as 'psychosis.'
- Chief Medical Officer Christopher Kenney reported the rate was 'hovering around 1% or under,' adding that these events were short in duration and reversible without long-term negative effects.
- Shares of the drug developer tumbled more than 25% in after-hours trading, though patients already enrolled in the trials will continue their treatment.
- Xenon is evaluating dose adjustments to improve tolerability while confirming the pause does not impact its epilepsy program, for which it submitted a Food and Drug Administration application.
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Xenon pauses new enrollment in depression drug trials over side-effect concerns - Regional Media News
By Kamal Choudhury Sept 17 (Reuters) - Xenon Pharmaceuticals on Thursday said it has temporarily paused enrolling new patients in clinical studies testing its experimental drug for major and bipolar depression, following reports of mental and nervous system-related side effects. Shares of the drug developer [...]
Xenon pauses new enrollment in depression, bipolar disorder trials over side-effect concerns
Sept 17 (Reuters) - Xenon Pharmaceuticals on Thursday said it has temporarily paused enrolling new patients in clinical studies testing its experimental drug for major depression and bipolar disorder, following reports of mental and nervous system-re...
Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on ...
New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectivelyEnrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data…
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Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical Program
New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectivelyEnrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data…
Xenon Pharmaceuticals Inc. (XENE) Discusses Azetukalner NDA Submission for Focal Seizures and Psychiatry Program Update Transcript
Xenon Pharmaceuticals Inc. (XENE) Discusses Azetukalner NDA Submission for Focal Seizures and Psychiatry Program Update September 17, 2026 4:30 PM EDT Company Participants Colleen Alabiso – Senior Vice President of Corporate AffairsIan Mortimer – President, CEO & DirectorChristopher Kenney – Chief Medical OfficerDarren Cline – Chief Commercial Officer Conference Call Participants Paul Matteis – Stifel, [...]
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