UniQure submitted applications to the FDA and the UK MHRA seeking marketing approval for its Huntington’s gene therapy AMT-130, aiming for a priority review decision. The Dutch company is requesting accelerated approval based on previously announced three-year data showing AMT-130 could slow disease progression. The filing arrives after a difficult year of disputes with regulators over study design and the use of external controls, amid concerns related to how patients were compared. UniQure said it completed the UK submission as well, keeping the program’s global review timeline moving. If granted, AMT-130 would mark a potential first for disease-modifying therapy targeting the underlying cause of Huntington’s disease, shifting expectations for future gene therapy programs that face similar evidentiary and trial-control questions.