Denali: FDA To Review BLA Seeking Accelerated Approval For Tividenofusp Alfa

(RTTNews) - Denali Therapeutics (DNLI) announced that the FDA has accepted for review the Biologics License Application seeking accelerated approval for tividenofusp alfa for the treatment of Hunter syndrome. The FDA granted the BLA Priority Review with a PDUFA target action date of January 5, 2026. The BLA submission is supported by data from the open-label, single-arm Phase 1/2 study of tividenofusp alfa in 47 participants with Hunter syndrome.

Carole Ho, Chief Medical Officer and Head of Development of Denali Therapeutics, said: "If FDA-approved, tividenofusp alfa would mark the first significant advancement in nearly two decades for enzyme replacement therapy for individuals living with Hunter syndrome because of its potential for delivery to tissues throughout the brain and the body."

For More Such Health News, visit rttnews.com.