08:38 AM EDT, 07/07/2025 (MT Newswires) -- Denali Therapeutics ( DNLI ) said Monday the US Food and Drug Administration accepted its biologics license application for tividenofusp alfa to treat Hunter syndrome and granted it priority review.

The regulator set January 5, 2026 as the target decision date under the accelerated approval pathway, the company said.

Tividenofusp alfa is designed to deliver the missing IDS enzyme to both the body and brain, and cross blood-brain barrier into the brain, which current therapies are not able to cross, Denali said.

The application is based on phase 1/2 trial results in 47 patients, while a separate late-stage study is underway to support worldwide regulatory approvals, the company said.

Shares of the company were up over 1% in recent premarket activity.