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 ...
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...
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 ...
Raymond James and Cantor both released bullish notes on uniQure (QURE) Tuesday following an update on the company's ...
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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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