Posted by Michael Wonder on 11 Mar 2021
Denali Therapeutics announces fast track designation granted by the U.S. FDA to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome
11 March 2021 - Denali Therapeutics today announced that the U.S. FDA has granted fast track designation to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome.
DNL310, Denali’s lead investigational brain-penetrant enzyme replacement therapy, is under evaluation in a Phase 1/2 study in patients with Hunter syndrome as a potential treatment for both central nervous system and peripheral manifestations of the disease.
