European Commission grants marketing authorisation for DAYBU

Key points

• DAYBU (trofinetide) approved for Rett syndrome in EU
• Acadia Pharmaceuticals to market the drug
• Neuren to receive milestone payments and royalties

Full summary

Neuren Pharmaceuticals announced that its partner, Acadia Pharmaceuticals, has received marketing authorization from the European Commission for DAYBU (trofinetide) to treat neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. DAYBU is the first treatment approved for Rett syndrome in the European Union. Acadia plans to launch the drug in Germany in early Q4 2026. Neuren is entitled to a US$35 million milestone payment upon the first commercial sale, potential sales milestone payments of up to US$170 million, and tiered royalties from mid-teens to low-20s percent of net sales.

Outlook

Neuren expects to benefit financially from the approval and commercial launch of DAYBU in the EU, with potential milestone payments and royalties.