UniQure disclosed that FDA staff strongly recommended a randomized, double‑blind, sham surgery‑controlled study for its Huntington’s disease gene therapy AMT‑130, saying existing single‑arm/external control data are insufficient for a marketing application. The agency’s stance could delay approval by two to three years and raises complex ethical and design questions around sham surgery controls. UniQure said it plans to request a Type B meeting with the FDA; the company’s shares plunged on the announcement, reflecting investor concern about timeline and regulatory expectations.