Denali Therapeutics Inc. has announced the publication of results from an open-label Phase 1/2 clinical trial of its investigational enzyme replacement therapy, tividenofusp alfa (DNL310), for the treatment of Hunter syndrome (mucopolysaccharidosis type II, MPS II). The results, published in the January 1, 2026 issue of The New England Journal of Medicine, showed that tividenofusp alfa treatment led to reduction and normalization of key disease biomarkers, stabilization or improvement in clinical endpoints such as adaptive behavior, cognition, and hearing, and normalization of liver volume. The most common treatment-related adverse events were infusion-related reactions, which decreased with continued use. Tividenofusp alfa is currently under FDA Priority Review, with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2026.

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