Portnoy Law Firm Announces Class Action On Behalf Of Uniqure N.V. Investors
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email:..., to discuss their legal rights, or join the case via . The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors' options for pursuing claims to recover their losses.
On November 3, 2025, uniQure issued a press release“announc[ing] that it received feedback from the U.S. Food and Drug Administration (FDA) during a recent pre-Biologics License Application (BLA) meeting regarding AMT-130, an investigational gene therapy for Huntington's disease (HD).” The press release stated that,“based on the discussions at the meeting, uniQure believes that the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission.” uniQure described this development as“a key shift from prior communications with the FDA in multiple Type B meetings over the past year” and said that,“[c]onsequently, the timing of the BLA submission for AMT-130 is now unclear.” On this news, uniQure's stock price fell $33.40 per share, or 49.34%, to close at $34.29 per share on November 3, 2025.
The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing. The Firm's founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.
Lesley F. Portnoy, Esq.
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