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FDA Extends Review Period for Denali's Hunter Syndrome Treatment
Denali received a review extension from the Food and Drug Administration for its Hunter syndrome treatment, with the new decision date set for April 5, 2026.
- Denali announced that the Food and Drug Administration extended its review period for the drug tividenofusp alfa, targeting a new decision date of April 5, 2026.
- The extension follows Denalis submission of updated clinical pharmacology information in response to an FDA information request during the review process.
- This delay is significant for patients with Hunter syndrome, a genetic disorder affecting enzyme production, as it impacts potential access to innovative treatments.
Why It Matters
The extension of the review period for Denalis treatment underscores the ongoing challenges in bringing new therapies to market. It highlights the importance of thorough evaluations to ensure safety and efficacy for conditions like Hunter syndrome, which lacks effective current treatments.