On November 3, 2025, uniQure issued a press release revealing that the FDA notified the company that data for its AMT-130, an investigational gene therapy for Huntington’s disease, did not provide sufficient evidence to support uniQure’s Biologics License Application (“BLA”) submission. Specifically, uniQure disclosed that the company believes the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 may be adequate to provide the primary evidence in support of a BLA submission, and that the timing of the BLA submission for AMT-130 is now unclear as a result.
On this news, the price of uniQure’s stock fell over 50%, from a close of $67.69 on October 31, 2025, to close at $34.29 on November 3, 2025.
If you have any questions or would like to discuss this investigation, please contact Kessler Topaz Meltzer & Check, LLP: Jonathan Naji, Esq. (484) 270-1453 or via e-mail at info@ktmc.com.
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