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 despite strong clinical data.
Uniqure stock doubles as FDA points to a BLA in Huntington’s
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
UniQure Shares Double After FDA Agreement on Pathway for Huntington's Disease Treatment
UniQure shares more than doubled after the company reached agreement with the Food and Drug Administration on key elements of an accelerated approval pathway for AMT-130, a potential treatment for Huntington's disease.
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
QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug
Qure N.V. QURE surged 109.7% after it announced reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130, a one-time administered investigational gene therapy, which is being developed to treat Huntington’s disease.
Hosted on MSN1d
uniQure Stock Hits 18-Month High After FDA Agreement Clears Pathway For Huntington’s Treatment: Retail Gets More Optimistic
Shares of gene therapy company uniQure more than doubled on Tuesday before trimming some gains, reaching their highest levels ...
BioPharma Dive1d
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 ...
pharmaphorum15h
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 ...
BioSpace1d
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 ...
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 ...
Why Is uniQure Stock Skyrocketing On Tuesday?
Qure stock surges after FDA agrees on an accelerated approval pathway for its Huntington's disease treatment, AMT-130.
bovnews1d
uniQure’s (QURE) Stock Soars on FDA’s Accelerated Approval Pathway: A Game-Changer in Gene Therapy
Qure has reached an agreement with the U.S. Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130, its gene therapy treatment aimed at Huntington’s disease.
uniQure’s AMT-130 Gene Therapy for Huntington’s Disease: A Promising Pathway to Accelerated Approval
William Blair analyst Sami Corwin has maintained their bullish stance on QURE stock, giving a Buy rating today.Pick the best stocks and ...
hdbuzz.net1d
Moving into the Fast Lane: uniQure and the FDA Are on the Same Track for Accelerated Approval
In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of ...