FDA accepts BLA and grants Priority Review for ifezuntirgene inilparvovec under Accelerated Approval, PDUFA date May 1, 2027

uniQure announced the FDA accepted its Biologics License Application and granted Priority Review for ifezuntirgene inilparvovec, its gene therapy for Huntington's disease, submitted under the Accelerated Approval pathway. The FDA set a PDUFA target action date of May 1, 2027.

Detected & updated continuously · Source: Nebula