10:36 AM EDT, 04/02/2025 (MT Newswires) -- Denali Therapeutics ( DNLI ) said Wednesday it has submitted a biologics license application to the Center for Drug Evaluation and Research of the US Food and Drug Administration for accelerated approval of its Hunter syndrome investigational therapeutic, tividenofusp alfa.

Denali said it expects to complete the rolling submission in the first half of May, with a potential commercial launch in the US in late 2025 or early 2026.

Shares were up 6.6% in recent trading.

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