The FDA reversed course on uniQure’s Huntington’s disease program AMT-130, clearing the way for the company to submit for accelerated approval. uniQure said it can file in the third quarter after the agency deemed three-year analysis data from its Phase I/II study acceptable for a marketing application. The development follows an earlier stance that required additional clinical trial evidence, now rejected by the FDA’s latest position. uniQure also said FDA and the company aligned during a Type B meeting on a confirmatory trial design that may not require a sham-controlled element. The FDA’s shift is another sign of changing regulatory approach for gene therapies and could reshape timelines for other accelerated-approval strategies in rare neurodegeneration.