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Neuren’s Partner Acadia Pushes for EU Re-Examination of Trofinetide Approval
9:58am on Tuesday 3rd of March, 2026 AEDT
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Pharmaceuticals
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Neuren’s Partner Acadia Pushes for EU Re-Examination of Trofinetide Approval
9:58am on Tuesday 3rd of March, 2026 AEDT
Key Points
Acadia to request CHMP re-examination of trofinetide’s EU marketing refusal
CHMP cited limited treatment effect and study design concerns in refusal
Trofinetide already approved in US, Canada, and Israel for Rett syndrome
Neuren supports re-examination amid significant unmet need in Europe
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