12:30 PM EDT, 03/25/2026 (MT Newswires) -- Denali Therapeutics ( DNLI ) said Wednesday the US Food and Drug Administration has granted accelerated approval to Avlayah to treat neurologic manifestations of Hunter syndrome in children weighing at least 5 kg before advanced neurological impairment.

The approval was based on phase 1/2 trial results showing a 91% reduction in cerebrospinal fluid heparan sulfate levels, a key disease biomarker, by week 24 of treatment, the company said.

Continued approval of Avlayah may depend on data from an ongoing confirmatory phase 2/3 study, the company said.

With the FDA approval, Denali said it received a rare pediatric disease priority review voucher that may be used for a future marketing application or transferred to another sponsor.

Shares of Denali Therapeutics ( DNLI ) were up 4.6% in Wednesday trading.

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