The EMA reversed its earlier stance on Acadia Pharmaceuticals’ trofinetide (Daybu), moving from a February rebuff to a CHMP recommendation to approve the therapy for neurobehavioral symptoms of Rett syndrome. The update means Daybu’s review file is back in the approval pathway after regulators took another look, underscoring how the EMA can pivot when additional analyses or clarifications are provided. For Acadia, the change is a potential inflection point as it seeks to translate regulatory momentum into a commercial launch timeline.