ASX:NEUPharmaceuticals
Neuren Pharmaceuticals (ASX:NEU) Is Down 16.1% After EMA Setback on Trofinetide Approval Prospects
Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals recently received a negative trend vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use on trofinetide’s marketing authorisation application for Rett syndrome in Europe, and Acadia plans to request a re-examination of the decision.
This setback highlights how regulatory assessments can differ across regions even for a rare-disease therapy already approved in the US, Canada and Israel, adding...