Denali Therapeutics' Hunter Syndrome Drug Review Extended by FDA

By Katherine Hamilton

Denali Therapeutics got an extension from the Food and Drug Administration for the review of its treatment for the genetic disorder Hunter syndrome.

The target date for the license application review of the drug known as tividenofusp alfa is now April 5, 2026, extended from Jan. 5, the San Francisco biotechnology company said Monday.

Denali had submitted updated clinical pharmacology information in response to an information request from the FDA as part of the review process. The FDA classified the submission as a major amendment to the application, automatically extending the review by three months.

The updated information is not related to efficacy, safety or biomarkers, Denali said. The company believes the information doesn't affect clinical pharmacology or benefit-risk conclusions of the application.

Denali is seeking accelerated approval for tividenofusp alfa. The drug is designed to treat mucopolysaccharidosis type II, also known as Hunter syndrome, which affects the body's ability to break down complex sugar molecules.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

October 13, 2025 16:53 ET (20:53 GMT)