The FDA set a May 1 target action date for uniQure’s Huntington’s disease gene therapy ifezuntirgene inilparvovec after accepting the company’s Biologics License Application (BLA) for Priority Review. The agency also signaled it may convene an advisory committee meeting, likely the Cellular, Tissue, and Gene Therapies Advisory Committee. The acceptance marks a reversal of prior FDA opposition described by the company, following investor caution tied to nuances in long-term data and ongoing safety considerations. The treatment uses uniQure’s miQURE microRNA gene-silencing platform designed to reduce huntingtin expression. Even with the review milestone, shares were reported lower in early trading as investors focused on the timing and the remaining evidentiary questions before the agency’s decision.