Denali Therapeutics (DNLI) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for tividenofusp alfa for the treatment of individuals with Hunter syndroms. This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome. Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway.
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