The FDA reversed course on uniQure’s Huntington’s disease gene therapy, clearing a path for the company to submit a marketing application for accelerated approval. UniQure said regulators would accept a three-year analysis from the phase I/II AMT-130 study as sufficient for the filing after a recent meeting with FDA officials. Separately, reporting on the same FDA shift described the agency giving uniQure renewed flexibility following earlier objections and disagreements with former FDA leadership. UniQure indicated the accelerated BLA submission is expected in the third quarter, with the company preparing for review under a revised regulatory pathway. Market impact is immediate: shares surged after the update, reflecting investor appetite for FDA clarity in rare neurodegeneration where evidence expectations have been a key gating item.