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.
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
Raymond James and Cantor both released bullish notes on uniQure (NASDAQ:QURE) Tuesday in the wake of news that the company ...
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Leerink raised the firm’s price target on uniQure (QURE) to $44 from $26 and keeps an Outperform rating on the shares. The firm notes the ...
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
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The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...
Verition Fund Management LLC lowered its position in uniQure (NASDAQ:QURE – Free Report) by 77.9% during the third quarter, ...
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.
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