QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug
Qure N.V. QURE surged 109.7% after it announced reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130, a one-time administered investigational gene therapy, which is being developed to treat Huntington’s disease.
UniQure shares soar on chance of speedy approval for Huntington’s therapy
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an accelerated approval application.
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 AMT-130 Gene Therapy for Huntington’s Disease: A Promising Pathway to Accelerated Approval
William Blair analyst Sami Corwin has maintained their bullish stance on QURE stock, giving a Buy rating today.Pick the best stocks and
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.
uniQure soars as it aligns regulatory path for Huntington’s candidate 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 Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130 in Huntington’s disease.
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may
Moving into the Fast Lane: uniQure and the FDA Are on the Same Track for Accelerated Approval
In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of drugs for Huntington’s disease.
uniQure stock rockets 90% on FDA update for AMT-130
UniQure (NASDAQ:QURE) stock shot up 90% Tuesday morning on news that the company had reached an agreement with the FDA on key elements for an accelerated approval pathway for its drug AMT-130 in the treatment of Huntington’s disease.
uniQure announces alignment with FDA on elements of approval path for AMT-130
N.V. announced that the company reached agreement with the U.S. Food and Drug Administration, FDA, on key elements of an
uniQure's AMT-130: A Bold Step For Huntington's, But Not Without Hurdles
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
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uniQure rockets on map to market for Huntington's therapy
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
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uniQure Stock Hits 18-Month High After FDA Agreement Clears Pathway For Huntington’s Treatment: Retail Gets More Optimistic
Shares of gene therapy company uniQure more than doubled on Tuesday before trimming some gains, reaching their highest levels ...
Why Is uniQure Stock Skyrocketing On Tuesday?
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.