Talha Qureshi
Mon, November 17, 2025 astatine 11:15 AM CST 2 min read
Earlier successful September, uniQure N.V. (NASDAQ:QURE) presented captious results from a three-year survey of their experimental cistron therapy called AMT-130, aimed astatine treating Huntington’s disease. The results showed a important simplification successful illness progression.
However, careless of the encouraging results, the FDA connected November 3 provided antagonistic feedback for AMT-130. As per the management, the FDA nary longer thinks the information from their aboriginal Phase I/II studies of AMT-130 is capable to enactment their main grounds for getting support to merchantability the therapy. As a result, the timing for the pre-Biologics License Application for AMT-130 is present unclear.
Analyst Joseph Thome from TD Cowen noted that management’s assurance successful the information and imaginable of AMT-130 remains robust. He mentioned the institution is successful progressive engagement with the FDA to research a viable mode forward. Thome remains assured successful the company’s quality to code these concerns effectively.
uniQure N.V. (NASDAQ:QURE) is simply a biotechnology institution based successful the Netherlands that develops cistron therapies designed to beryllium fixed erstwhile and perchance cure terrible familial diseases.
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Disclosure: None. This nonfiction is primitively published astatine Insider Monkey.

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