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UniQure, 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 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 Rating Scale (cUHDRS) can serve as an intermediate clinical endpoint for its review, along with the use of neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF) as a biomarker for efficacy.
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.
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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 ...
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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 ...
Investor's Business Daily on MSN
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UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's Drug
UniQure stock doubled Tuesday after the company reached a testing agreement with the FDA for its Huntington's disease ...
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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 ...
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