Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late 2025 or early 2026.
Denali Therapeutics today announced that the company’s initiation of a rolling submission of a biologics license application for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome has been received by the Center for Drug Evaluation and Research of the US FDA.
