H.C. Wainwright Recommends EU Approval for Acadia's DAYBU
The CHMP last week issued a positive re-examination opinion recommending EU approval for Acadia's DAYBU, or trofinetide, after narrowing the label to neurobehavioral symptoms of Rett syndrome and restricting the age range, with the decision based on Phase 3 LAVENDER trial results showing clinically meaningful improvements, H.C. Wainwright tells investors in a research note. The European Commission will now make the final decision, and potential orphan exclusivity could provide up to 10 years of protection if upheld, the firm, which has a Buy rating and $37 price target on Acadia shares, says.