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.
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
UniQure (QURE) stock shot up 90% on news the company had reached an agreement with the FDA on an accelerated approval pathway ...
Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on uniQure (QURE – Research Report). The associated price target ...
In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of ...
Raymond James and Cantor both released bullish notes on uniQure (NASDAQ:QURE) Tuesday in the wake of news that the company ...
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.
William Blair analyst Sami Corwin has maintained their bullish stance on QURE stock, giving a Buy rating today.Pick the best stocks and ...
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