Acadia Pharma Submits MAA To EU Agency For Approval Of Trofinetide In Rett Syndrome

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) Tuesday, announced the submission of a Marketing Authorization Application or MAA to the European Medicines Agency or EMA for its Trofinetide, targeting 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 or IGF-1, is already approved in the United States and Canada for the treatment of Rett syndrome.

The MAA submission is based on positive outcomes from the pivotal Phase 3 LAVENDER study, which evaluated the efficacy and safety of Trofinetide.

ACAD is currently trading at $17.33 down 3.18 percent or $0.57 on the Nasdaq.