European Commission Approves DAYBU for Rett Syndrome

Acadia Pharmaceuticals announced that the International — European Commission has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. This approval makes DAYBU the first and only treatment approved for Rett syndrome in the European Union. The authorization is based on results from the Phase 3 LAVENDER study, which demonstrated statistically significant and clinically meaningful improvements in core features of Rett syndrome. With this approval, DAYBU is authorized to be marketed in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Acadia will now begin pricing and reimbursement negotiations with relevant national authorities to potentially bring DAYBU to patients across the EU. The approval follows a positive opinion from the European Union — European Medicines Agency's advisory committee in June 2026. Trofinetide is already approved in the United States, Canada, and Israel under different brand names.