DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation

Denali Therapeutics Inc. (DNLI) announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter syndrome (MPS II).Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).Shares of DNLI have lost 1.9% in the past six months compared with the industry’s 8.3% decline.Image So ...