UniQure filed applications with the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its gene therapy targeting the underlying cause of Huntington’s disease. The company requested priority review from the FDA, aiming for a decision in about eight months. UniQure based the filings on previously announced three-year data showing AMT-130 could significantly slow disease progression, and it also submitted information to UK regulators. The company is seeking accelerated approval, which would require later confirmatory evidence. The submission follows earlier regulatory friction around trial controls and analysis choices, illustrating how Huntington’s gene therapy development has depended heavily on FDA’s standards for evidence quality in complex surgical gene therapy studies.