Denali Therapeutics gets FDA review extension for tividenofusp alfa

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* Denali Therapeutics (NASDAQ:DNLI [https://seekingalpha.com/symbol/DNLI]) has announced that the U.S. FDA has extended its review date of the marketing application for tividenofusp alfa, a treatment for Hunter syndrome.
* The new target action date is now set for April 5, 2026, instead of the previously scheduled January 5, 2026.
* This delay comes after Denali provided updated clinical pharmacology data in response to a request from the FDA during the standard review process.
* This extension is not related to the drug's efficacy, safety, or biomarkers, the company said [https://seekingalpha.com/pr/20263659-denali-therapeutics-announces-fda-review-extension-of-bla-for-tividenofusp-alfa-for-the].

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