10:51 AM EST, 01/08/2025 (MT Newswires) -- Denali Therapeutics ( DNLI ) said Wednesday the US Food and Drug Administration has given breakthrough therapy designation for tividenofusp alfa to treat people with Hunter syndrome, a rare genetic disease.

The designation was created to quicken the development and review of candidate drugs to treat serious or life-threatening diseases, the company said.

The label is in addition to fast track designation, orphan drug designation, and rare pediatric disease designation that were all previously given by the FDA for tividenofusp alfa to treat Hunter syndrome, Denali added.

Denali said it plans to file a biologics license application for tividenofusp alfa early this year.

The company's shares were rising 1.6% in recent trading.

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