 SOUTH SAN FRANCISCO, Calif., March 11, 2021 GLOBE NEWSWIRE -- Denali Therapeutics Inc. NASDAQ: DNLI, a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier BBB for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration FDA has granted Fast Track designation to ETV:IDS DNL310 for the treatment of patients with Hunter syndrome MPS II. DNL310, Denalis lead investigational brain-penetrant enzyme replacement therapy, is under evaluation in a Phase 12 study in patients with Hunter syndrome as a potential treatment for both central nervous system CNS and peripheral manifestations of the disease. 