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 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 serve as the primary basis for a Biologics License Application (BLA) for Accelerated Approval ~ ~ FDA agrees that the composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval ~ ~ Conference call today at 8:30 a.
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’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
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 Shares Double After FDA Agreement on Pathway for Huntington's Disease Treatment
UniQure shares more than doubled after the company reached agreement with the Food and Drug Administration on key elements of an accelerated approval pathway for AMT-130, a potential treatment for Huntington's disease.
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
Gene therapy developer's stock doubles after FDA grants accelerated approval
The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the company’s share price on Tuesday.
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 since mid-June 2023. The surge came after uniQure announced it had reached an agreement with the U.
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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 ...
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 ...
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.
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 ...