Denali’s brain-penetrant therapy shows 91% biomarker reduction in Hunter syndrome
Denali Therapeutics (NASDAQ:DNLI) announced promising Phase 1/2 results for tividenofusp alfa (DNL310) in the treatment of Hunter syndrome, with the data published in The New England Journal of Medicine supporting an FDA Priority Review. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for April 5, 2026.







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