Acadia Gets European Commission Nod for Daybu in Rett Syndrome

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โดย Zacks Investment Research·EUUS·Read original
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Acadia Pharmaceuticals announced that the European Commission has granted marketing authorization for Daybu, also known as trofinetide, to treat neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. The approval makes Daybu the first and only treatment approved for this indication in the European Union, covering all 27 EU member states plus Iceland, Liechtenstein and Norway. Acadia will now begin pricing and reimbursement negotiations with national authorities to bring the therapy to patients across the EU. The decision follows a positive opinion from the European Medicines Agency's advisory committee in June 2026 and is supported by data from the pivotal phase III LAVENDER study, which met its co-primary endpoints. In the United States, the drug is marketed as Daybue and was approved by the FDA in 2023 for patients aged two years and older; it is also available in Canada and Israel. Acadia raised its 2026 Daybue sales projection to $480-$510 million from the previous range of $460-$490 million, while maintaining Nuplazid sales guidance of $760-$790 million.

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European Commission approval for Daybu in Rett syndrome, first in EU, expands market and raises sales guidance.

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