• CHMP positive opinion recommends EU marketing authorization for DAYBU®
• DAYBU® would be the first treatment for Rett syndrome neurobehavioral symptoms in the EU
• Neuren entitled to $35M and royalties if DAYBU® is approved and launched

Neuren Pharmaceuticals Ltd. announced that its partner, Acadia Pharmaceuticals Inc., received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of DAYBU® (trofinetide) for treating neurobehavioral symptoms of Rett syndrome in the EU. If approved by the European Commission, DAYBU® would become the first treatment for this indication in the EU. Neuren is entitled to receive $35 million following the first commercial sale and additional milestone payments and royalties based on sales. Neuren CEO Jon Pilcher expressed delight at the CHMP's recommendation, highlighting the potential impact on patients and caregivers.

Neuren entitled to $35M and royalties if DAYBU® is approved and launched

Neuren anticipates potential milestone payments and royalties from DAYBU® sales if approved in the EU.