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Is Regulatory Scrutiny of AMT-130 Quietly Rewriting uniQure’s (QURE) Gene Therapy Investment Story?
In recent weeks, uniQure has faced intensified scrutiny as multiple law firms advanced securities class actions alleging misleading disclosures around FDA interactions and the pivotal study design for ...
LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...
--uniQure N.V., a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced updated interim data including up to 30 months of follow-up ...
Gene Therapy Meets Regulatory Reality: The FDA–uniQure Clash Over a Promising Huntington’s Treatment
A new controversy surrounding the U.S. Food and Drug Administration (FDA) and biotechnology firm uniQure has ignited debate across the pharmaceutical industry about how breakthrough treatments should ...
uniQure has acknowledged that what it called “game changing” data in September showing significant slowing of Huntington’s disease (HD) progression in patients treated with its gene therapy candidate ...
(RTTNews) - uniQure N.V. (QURE), a gene therapy company, announced Monday that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a Type A meeting ...
CEO Matthew Kapusta reported, "in the third quarter, we announced positive top line data from our pivotal Phase I/II study of AMT-130 in Huntington's disease, the first gene therapy to demonstrate ...
FDA's Rigid Approach Adds Uncertainty To uniQure's Accelerated Pathway For Huntington's Gene Therapy
William Blair highlighted that the key difference between this meeting and the company's prior meetings with the FDA is that Nicole Verdun was not present. Vinay Prasad was also not in the meeting.
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