EU Approves DAYBU as First Rett Syndrome Treatment, Opening 30-Country Market
ACAD sits 52% above its 52-week low of $19.69.
Summary
The European Commission granted marketing authorization for DAYBU (trofinetide) for Rett syndrome, making it the first and only approved treatment in the EU. This follows the positive CHMP opinion in June and expands Acadia's commercial footprint to all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on the Phase 3 LAVENDER study and addresses a significant unmet need in a rare neurodevelopmental disorder. Acadia will now begin pricing and reimbursement negotiations with national authorities, a key step toward revenue generation in Europe. With DAYBUE already approved in the US and Canada, this approval strengthens Acadia's global franchise and supports its growth outlook.
At the time of this announcement, ACAD was trading at $30.02 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.1B. The 52-week trading range was $19.69 to $30.96. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.