In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy on June 18, 2026 Accelerated AMT-130 Approved Biologics License Application Breakthrough Therapy cUHDRS gene therapy Huntington 's disease NEFL gene Phase I/II study RMAT uniQure United States Food and Drug Administration +
UniQure stock surges after FDA U-turn clears path to gene therapy filing on June 17, 2026 Accelerated AMT-130 Approved Blackfoot language Clinical Research gene therapy Huntington 's disease Phase QURE surge U-turn uniQure United States Food and Drug Administration +
FDA Rejects UniQure's AMT-130 Gene Therapy Data for Huntington's, Demands New Sham-Controlled Trial on March 06, 2026 AMT-130 gene therapy Huntington 's disease Phase 1/2 data sham-controlled trial uniQure United States Food and Drug Administration +
UniQure's Huntington's Gene Therapy AMT-130 Faces FDA Roadblock, Requiring New Trial on March 02, 2026 AMT-130 gene therapy Huntington 's disease Phase 3 sham surgery uniQure United States Food and Drug Administration +
UniQure restates FDA’s negative feedback on Huntington’s trial on December 05, 2025 AMT-130 antibody collaboration AstraZeneca external control group Feedback - system communication gene therapy Nerve Degeneration Neurimmune uniQure United States Food and Drug Administration +
uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy on November 03, 2025 Accelerated AMT-130 Approved Clinical Trials gene therapy Huntington 's disease regulatory setback uniQure United States Food and Drug Administration +
uniQure's Gene Therapy AMT-130 Significantly Slows Huntington's Progression in Pivotal Trial on September 25, 2025 AMT-130 Approved Clinical Trials Disease Progression gene therapy huntingtin-lowering Huntington 's disease Nerve Degeneration uniQure United States Food and Drug Administration +