04:29 PM EDT, 10/13/2025 (MT Newswires) -- Denali Therapeutics ( DNLI ) said late Monday that the US Food and Drug Administration, or FDA, has extended the review timeline for its application seeking accelerated approval of its drug candidate to treat Hunter syndrome.

The target date for the FDA's review of the experimental drug, tividenofusp alfa, has been extended to April 5, 2026 from January 5, 2026.

Shares in the company were down nearly 5% in recent after-hours trading.