Berman Tabacco, a national law firm representing investors, announces that it is investigating potential securities law violations by uniQure N.V. (Nasdaq: QURE) (“uniQure” or the “Company”), a Netherlands-based developer of gene therapies with offices in Lexington, Massachusetts.
About the Investigation
On September 24, 2025, uniQure issued a press release announcing, “positive topline data from the pivotal Phase I/II study of AMT-130 for the treatment of Huntington’s disease.” Shares closed at $47.50 per share on September 24, 2025, up $33.84 or approximately 248%.
On September 25, 2025, uniQure issued a press release announcing the pricing of a public offering of over 5.7 million ordinary shares at $47.50.
On November 3, 2025, uniQure issued a press release announcing, “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 Company stated, “[t]hough final meeting minutes have not yet been received, 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.” On November 3, 2025, shares close at $34.29 per share, down $33.40 per share or approximately 49%.
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