The FDA reversed course again on uniQure’s Huntington’s disease gene therapy AMT-130, agreeing that a three-year analysis of early-stage data is acceptable to support an accelerated marketing authorization filing. UniQure said it plans to submit the application in the third quarter. The agency’s updated stance followed discussion at a type B meeting, where FDA and uniQure also aligned on a confirmatory trial design that may avoid a sham-controlled element previously viewed as contentious. Multiple reports tied the renewed flexibility to leadership changes at FDA. In parallel, the renewed path triggered a sharp market reaction to uniQure shares as investors priced in a higher probability of a future approval decision.