FDA Extends Review of DNLI's Hunter Syndrome Drug by Three Months

Key Takeaways The FDA extended review of Denali's tividenofusp alfa BLA for Hunter syndrome treatment.The timeline moved from Jan. 5 to April 5, 2026, after Denali submitted new pharmacology data.The extension isn't tied to safety or efficacy, and no extra data was requested by the FDA.Denali Therapeutics Inc. (DNLI) announced that the FDA has extended its review timeline of the Biologics License Application (“BLA”) for pipeline candidate, tividenofusp alfa.The BLA is seeking accelerated approval of tividen ...