UniQure reiterated that FDA staff conveyed negative feedback on its AMT‑130 Huntington’s disease dossier, indicating current data likely fall short for approval. The company said it received final meeting minutes and is preparing to urgently request follow‑up discussions with the agency in the coming quarter. The FDA’s position surprised investors and prompted a sharp share decline. UniQure stressed the robust clinical signal seen in a mid‑stage high‑dose cohort but acknowledged multiple regulatory scenarios remain, including additional patient enrollment or new trials to address agency concerns.