uniQure’s Huntington’s disease gene therapy ifezuntirgene inilparvovec cleared a key regulatory milestone as the FDA accepted its Biologics License Application under Priority Review and set a May 1 PDUFA target action date. The agency also signaled it may discuss the submission at a future advisory committee meeting, though no date was set. The decision reverses opposition surfaced earlier in the review timeline, uniQure said. The therapy uses the company’s miQURE gene-silencing platform, including a microRNA designed to silence huntingtin and address potentially toxic exon 1 fragments. Despite the regulatory progress, investors appeared cautious after the FDA timeline landed later than some expectations and as investors weigh results showing less slowing of progression in longer follow-up versus earlier data cuts.