DNLI - Denali nabs FDA's Fast Track status for DNL310 in Hunter syndrome

The FDA has granted the Fast Track designation to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome (mucopolysaccharidosis type II).DNL310, an investigational brain-penetrant enzyme replacement therapy developed by Denali Therapeutics ([[DNLI]] +11.1%) is currently undergoing a Phase 1/2 study to evaluate its effect in the central nervous system (“CNS”) and peripheral manifestations of the disease.The trial is currently enrolling patients for Cohort B and Cohort C is also in plans.In November, Denali announced Cohort A data demonstrating human biomarker proof-of-concept for its TV (Transport Vehicle) technology.

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Denali nabs FDA’s Fast Track status for DNL310 in Hunter syndrome