UniQure said it plans to submit a marketing application for its Huntington’s gene therapy AMT-130 (embrace) to UK regulators later this year after a positive meeting with drug regulators. The company cited a three-year analysis from ongoing studies that shows apparent slowing of disease progression at the highest dose. UniQure also pointed to planned engagement with the FDA in the second quarter to discuss potential Phase 3 trial design elements and to incorporate feedback on a four-year analysis expected in the third quarter. The company’s U.S. path remains uncertain after FDA demanded a new trial following earlier guidance. For the biotech sector, the update is a live example of how regional regulator dialogue and trial-readout design can change timelines for gene therapies in neurodegeneration.