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 despite strong clinical data.
FDA Agrees On Accelerated Approval Pathway For AMT-130 In Huntington's Disease; Stock Up 89%
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug
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 stock rockets 90% on FDA update for AMT-130
UniQure (QURE) stock shot up 90% on news the company had reached an agreement with the FDA on an accelerated approval pathway for its drug AMT-130 for Huntington’s disease.
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 stock doubles as FDA points to a BLA in Huntington’s
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
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
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 Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington's Disease
We are very pleased to reach agreement with the FDA on core components of an Accelerated Approval pathway for AMT-130,” said Walid Abi-Saab, M.D., chief medical officer of uniQure. “Our alignment reflects the strength of our data and collaborative discussions with the staff and senior management at FDA’s Center for Biologics Evaluation and Research (CBER).
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
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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 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 ...
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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 ...
Positive Outlook for uniQure’s AMT-130 Gene Therapy Drives Buy Rating Amid Regulatory Progress and Promising Data
Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on uniQure (QURE – Research Report). The associated price target ...
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.