FX.co ★ Acadia Pharma Submits MAA To EU Agency For Approval Of Trofinetide In Rett Syndrome

Acadia Pharmaceuticals Inc. (ACAD) has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Trofinetide, aimed at treating Rett syndrome in both adult and pediatric patients aged two years and older. Rett syndrome is a severe and complex neurodevelopmental disorder. Trofinetide, a synthetic analog of the N-terminal tripeptide of insulin-like growth factor 1 (IGF-1), is already approved in the United States and Canada for the treatment of this condition. The MAA submission is underpinned by positive results from the pivotal Phase 3 LAVENDER study, which assessed the efficacy and safety of Trofinetide. Currently, Acadia Pharmaceuticals is trading at $17.33, reflecting a decline of 3.18%, or $0.57, on the Nasdaq.