UniQure Huntington's Drug Faces FDA Setback, Shares Drop 19%
UniQure stock tumbles as FDA says AMT-130 gene therapy data insufficient for approval. Company seeks urgent Q1 2026 meeting to advance Huntington's disease treatment.
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FDA Feedback Rocks uniQure: Gene Therapy for Huntington’s Disease Delayed
UniQure's stock plummeted after the FDA unexpectedly decided that the current clinical trial data for its promising Huntington's disease therapy, AMT-130, is not adequate for immediate marketing application (BLA).
UniQure's AMT-130 Gene Therapy Success in Huntington's Disease
AMT-130 gene therapy for Huntington’s disease showed major success, statistically slowing progression by 75%. Experts see disease-modifying potential. It was well-tolerated. UniQure secured funding for a planned late 2026 U.S. launch.