UniQure (QURE) Stock Jumps on FDA Support for Accelerated AMT-130 Approval Path

UniQure (QURE) shares rose 12% in premarket trading on June 17, 2026, after the U.S. Food and Drug Administration (FDA) indicated support for an accelerated approval pathway for its investigational Huntington's disease gene therapy, AMT-130. The company announced the positive feedback following a recent Type B meeting with the agency. The FDA suggested that an accelerated approval pathway could be feasible, contingent on an early efficacy signal from UniQure’s ongoing Phase 1/2 study of AMT-130. This gene therapy is an AAV5-delivered treatment designed for Huntington's disease. UniQure plans to engage with the FDA in the third quarter of 2026 to discuss the design of a potential registrational study.