UniQure submitted applications to the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its Huntington’s disease gene therapy. The company asked for priority review with a decision targeted in about eight months and is also pursuing accelerated approval, while completing its regulatory strategy based on previously announced three-year data. The filing comes after a turbulent agency dialogue that included requests for a new double-blind trial design incorporating a sham surgery control group. UniQure’s current submission relies on a control comparison using Enroll-HD and follows the company’s earlier push that drew sharp criticism from regulators and external experts. If accepted, AMT-130 would represent a potential first approval for disease-modifying treatment in Huntington’s, with the timing and evidentiary bar likely to be closely watched by other gene-therapy developers.