The FDA reversed course on a closely watched Huntington’s disease gene therapy, clearing the path for uniQure (UniQure NV) to submit a U.S. marketing application. The decision supports an accelerated approval plan for AMT-130, following a recent agency discussion in which FDA agreed that three-year analysis data from an early-stage study could be considered “acceptable” for a marketing application. uniQure said it plans to file in the third quarter seeking accelerated approval. The move comes after previous FDA opposition attributed to the adequacy of the dataset for an approval package, and it follows other recent signals of shifting regulatory flexibility at the agency. For sponsors of rare neurodegeneration programs, the outcome is another datapoint in how regulators may weigh early clinical evidence when uncertainty persists. It also sets up a near-term milestone for developers preparing dossier packages for accelerated pathways under CBER review. Beyond AMT-130, the episode is likely to be tracked by the gene-therapy and rare-disease communities for its implications on what controls and follow-up timelines regulators consider sufficient for accelerated submissions.