FDA Grants Priority Review to uniQure's Gene Therapy for Huntington's Disease

uniQure N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for ifezuntirgene inilparvovec, an investigational gene therapy for Huntington's disease. The application received Priority Review designation, with a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. If approved, this could be the world's first disease-modifying treatment for Huntington's disease.