Denali Therapeutics Reports Positive Phase 1/2 Results for Tividenofusp Alfa in Hunter Syndrome
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Denali Therapeutics Inc. has reported positive results from a Phase 1/2 clinical trial of tividenofusp alfa for Hunter syndrome. The findings, published in The New England Journal of Medicine, indicate that the treatment reduced key disease biomarkers and stabilized or improved clinical endpoints, including adaptive behavior and cognition. The most common adverse events were infusion-related reactions, which diminished over time. Tividenofusp alfa is under FDA Priority Review, with a PDUFA date set for April 5, 2026.
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