The FDA reversed course again on uniQure NV’s Huntington’s disease gene therapy, clearing the company to submit an accelerated BLA for its AMT-130 treatment. Under the latest agreement, the agency said three-year analysis data from uniQure’s Phase I/II study are acceptable to support the marketing application timing now targeted for the third quarter. UniQure said the decision follows an FDA type B meeting during which the agency and the company aligned on a confirmatory trial design that may not require a sham-controlled element. The update follows prior FDA objections from former leadership that UniQure said had blocked the company’s path to filing. The regulatory turn marks another example of rapid policy evolution for accelerated pathways in rare-disease gene therapy, with potential implications for how sponsors assemble clinical evidence for accelerated approval submissions.