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Gene therapy developer's stock doubles
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.
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.
pharmaphorum
1d
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 ...
1d
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 ...
Hosted on MSN
2d
UniQure Stock Doubles After Striking A Deal With The FDA For Huntington's Drug
UniQure stock nearly doubled Tuesday after the company reached a testing agreement with the FDA for its Huntington's disease ...
1d
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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