uniQure said the FDA accepted its biologics license application for AMT-130 (ifezuntirgene inilparvovec) for Huntington’s disease and set a May 1, 2027 PDUFA action date after Priority Review acceptance. The company also said the FDA is tentatively planning to discuss the filing at a future advisory committee meeting, most likely the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). In parallel, the acceptance reduces one key regulatory hurdle compared with the earlier opposition the agency voiced in 2025 and earlier in 2026. Even so, investors appeared cautious after the news, with concerns including the later-than-expected action date and clinical dataset interpretation. For biopharma, the update underscores how gene-therapy timelines can hinge on FDA procedural decisions, including whether and when advisory committees are convened, even after BLA acceptance.