FDA has set a May 1 PDUFA target action date for uniQure’s Huntington’s disease gene therapy ifezuntirgene inilparvovec, following acceptance of its Biologics License Application (BLA) under Priority Review. The agency signaled it may discuss the submission at a future advisory committee meeting, tentatively without a scheduled date. The action reverses prior regulatory friction, according to the reporting, and marks another milestone for the Huntington’s community after decades without a disease-modifying therapy. uniQure said the acceptance removes regulatory risk, while noting that an adcomm discussion remains possible. Market reaction was cautious: the company’s shares dipped after the news, with investors pointing to the later-than-expected PDUFA date and the company’s data showing less disease slowing in some longer-term analyses than earlier shorter-term findings. The therapy uses uniQure’s gene-silencing miQURE platform, incorporating a microRNA intended to silence the huntingtin gene and a potentially toxic exon 1 protein fragment.