The Neuren Pharmaceuticals Ltd (ASX: NEU) share price has more than doubled in less than a month.
Neuren Pharmaceuticals (NEU) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for NNZ-2591.
Using bioluminescent protein to map tooth decay, Calcivis nets FDA blessing
SAN DIEGO & MELBOURNE, Australia--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder. Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.