uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington's Disease
We are very pleased to reach agreement with the FDA on core components of an Accelerated Approval pathway for AMT-130,” said Walid Abi-Saab, M.D., chief medical officer of uniQure. “Our alignment reflects the strength of our data and collaborative discussions with the staff and senior management at FDA’s Center for Biologics Evaluation and Research (CBER).
Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...
1d
William Blair analyst Sami Corwin has maintained their bullish stance on QURE stock, giving a Buy rating today.Pick the best stocks and ...
In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of ...
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on uniQure (QURE – Research Report). The associated price target ...
Qure stock rallies 110% on reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130 to ...
Dutch gene therapy company uniQure saw its shares rocket 86% to $13.57 today, after it reached agreement with the US Food and ...
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...
Crucially for the Netherlands-based biopharma company, the FDA has said that the composite Unified Huntington's Disease ...
Hosted on MSN1d
uniQure Stock Hits 18-Month High After FDA Agreement Clears Pathway For Huntington’s Treatment: Retail Gets More OptimisticShares of gene therapy company uniQure more than doubled on Tuesday before trimming some gains, reaching their highest levels ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback