Denali Therapeutics Inc. announced today, 2025‑10‑14, that the U.S. Food and Drug Administration has extended the review timeline of its Biologics License Application (BLA) for tividenofusp alfa (DNL310) in Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date was moved from January 5 2026 to April 5 2026, a three‑month extension that reflects a major amendment to the BLA.
The extension was granted after Denali submitted updated clinical pharmacology information in response to an FDA information request. The FDA classified the submission as a Major Amendment, which by regulation extends the review by three months, and no additional data were requested in the amendment letter. Denali emphasized that the new information does not affect the clinical pharmacology or benefit‑risk conclusions of the application.
Denali’s CEO, Ryan Watts, noted that the company remains focused on preparing for a potential approval and commercial launch of tividenofusp alfa. The extension provides additional time for the FDA to complete its review while maintaining the company’s overall regulatory timeline. Investors can view the delay as a routine regulatory milestone rather than a substantive setback to the product’s development trajectory.
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