UniQure said the FDA reversed course again on its Huntington’s disease gene therapy AMT-130, clearing the company to submit for accelerated approval in the third quarter. The latest U-turn follows the agency previously seeking additional evidence from another clinical trial source, according to the company. UniQure said FDA agreed that a three-year analysis of data from its Phase I/II study is acceptable to support a marketing application. The company also discussed aligning confirmatory-trial expectations with the FDA, describing a design that may avoid a potentially controversial sham-controlled element. Separately, reporting around uniQure also noted investor optimism tied to the FDA flexibility narrative after leadership changes associated with the departure of key FDA figures. The regulatory shift matters for other rare-disease developers because it signals that the agency may be more willing to accept specific evidentiary packages for accelerated pathways, depending on how data analysis timing and confirmatory design are structured.