Denali Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application $(BLA.AU)$ for tividenofusp alfa, a treatment for Hunter syndrome (MPS II), a rare genetic disorder. The FDA has granted Priority Review for the application, setting a target decision date of January 5, 2026, for potential accelerated approval. Tividenofusp alfa is designed to deliver the missing enzyme to the entire body and cross the blood-brain barrier into the brain, marking a potential significant advancement in enzyme replacement therapy for Hunter syndrome. This development also represents a pivotal milestone for Denali's TransportVehicle™ platform aimed at treating various lysosomal storage diseases and neurodegenerative disorders.
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