Neuren (NEU) – ASX Announcement:
13 March 2023 FDA approval of DAYBUE™ (trofinetide) - the first approved treatment for Rett syndrome Highlights:
Acadia Pharmaceuticals announces US FDA approval of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older
First and only approved treatment for Rett syndrome
Acadia expects DAYBUE to be available by the end of April 2023
Rare Pediatric Disease Priority Review Voucher (PRV) granted in connection with approval
Neuren to receive US$40 million on first commercial sale, royalties on net sales, potential sales milestone payments and one third of the market value of the PRV