The FDA set a May 1 PDUFA target action date for uniQure’s Huntington’s disease gene therapy ifezuntirgene inilparvovec (AMT-130) after accepting the company’s BLA under Priority Review. The agency also signaled it may convene an advisory committee meeting, potentially using the CTGTAC panel, though no date had been set at the time of the announcement. uniQure characterized the acceptance as an important milestone for a community that has waited generations for a disease-modifying option. While investors were cautious and shares moved lower in the immediate reaction, analysts noted the acceptance reduced regulatory risk. The decision extends a regulatory process that previously included heightened scrutiny and reversal of earlier FDA opposition.