UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.
uniQure’s (QURE) Stock Soars on FDA’s Accelerated Approval Pathway: A Game-Changer in Gene Therapy
Qure has reached an agreement with the U.S. Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130, its gene therapy treatment aimed at Huntington’s disease.
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
UniQure (NASDAQ:QURE) stock shot up 90% Tuesday morning on news that the company had reached an agreement with the FDA on key ...
William Blair analyst Sami Corwin has maintained their bullish stance on QURE stock, giving a Buy rating today.Pick the best stocks and ...
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.
Dutch gene therapy company uniQure saw its shares rocket 86% to $13.57 today, after it reached agreement with the US Food and ...
Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on uniQure (QURE – Research Report). The associated price target ...
In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of ...
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