FDA reversed course again for uniQure’s Huntington’s disease gene therapy, clearing the company to seek accelerated approval after previously objecting to the evidence base. Per uniQure disclosures cited by STAT+, the agency agreed that a three-year analysis of early AMT-130 data was acceptable to support a marketing application. uniQure said it will submit the accelerated approval filing in the third quarter. The decision marks a notable policy signal for cell and gene therapy evidence thresholds, especially after recent leadership departures at FDA’s relevant offices fueled speculation about whether flexibility had returned.