UniQure disclosed that the FDA no longer appears to view its Phase I/II AMT‑130 data as sufficient to support a Biologics License Application, reversing earlier signals that had encouraged the company to plan a near‑term filing. The change in stance prompted a sharp selloff in UniQure shares and leaves the timing of any submission unclear. Regulators’ greater caution about single‑arm or externally‑controlled gene therapy data underscores rising FDA scrutiny of evidence standards for precision genetic medicines and increases execution risk for developers relying on non‑randomized controls.