UniQure filed applications with the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its gene therapy intended to treat the underlying cause of Huntington’s disease. The company requested priority review, targeting a potential FDA decision in about eight months, and said the submission is based on previously announced three-year data. UniQure’s path has been turbulent, including FDA pressure to add controls after concerns about the company’s use of an external natural history dataset (Enroll-HD) instead of an in-study control group. The filing also follows a period of public dispute about data interpretation and trial design expectations.