UniQure has submitted marketing-authorization applications to the FDA and the UK’s MHRA for AMT-130, its Huntington’s gene therapy candidate. The Dutch company is also requesting priority review in the US, targeting an FDA decision in about eight months, and says the application is based on previously reported three-year data showing slower disease progression. The filing comes after a year of intense scrutiny around trial design and external controls, including FDA requests for a new double-blind study with sham-surgery controls. UniQure previously shifted from an in-study sham control to an external natural-history comparator, a change that drew sharp debate inside the agency. If accepted, the AMT-130 review could mark a landmark for gene therapies aimed at modifying the underlying cause of Huntington’s disease. The MHRA submission similarly tees up a parallel regulatory readout in the UK.