uniQure reported another reversal in its Huntington’s disease gene-therapy pathway after the U.S. FDA indicated that three-year analysis data from the Phase I/II study would be acceptable for an accelerated BLA filing for AMT-130. The company said it now expects to submit the BLA in the third quarter, after a type B meeting with FDA aligned on a confirmatory trial design that may avoid a controversial sham-controlled element. The move follows recent leadership changes at FDA and adds to a broader read-through across rare-disease sponsors that review stances may be more flexible than in prior months.