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uniQure N.V. INVESTIGATION: Kirby McInerney LLP Announces Investigation Into Potential Securities Fraud on behalf of Investors (QURE)

Key Takeaway: Kirby McInerney LLP is investigating potential claims against uniQure N.V. for securities fraud, focusing on the company's management practices. This comes after uniQure disclosed that the FDA no longer believes the data from Phase I/II studies of AMT-130 meets the necessary criteria for a Biologics License Application (BLA) submission. Consequently, the timeline for the BLA submission is now uncertain, severely impacting the company's stock price, which plummeted by approximately 49.33% shortly after the announcement.

Market Sentiment Analysis

CONCERNS & RISKS

  • uniQure faced an investigation over potential securities fraud.
  • The FDA has expressed concerns regarding data adequacy for AMT-130's BLA submission.
  • Share prices dropped nearly 50% following the announcement.

Full Press Release Details

NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against uniQure N.V. (“uniQure” or the “Company”) (NASDAQ:QURE). The investigation concerns whether the Company and/or members of its senior management may have violated federal securities laws or engaged in other unlawful business practices.
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On November 3, 2025, uniQure disclosed that the Company “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.” The Company added, “Consequently, the timing of the BLA submission for AMT-130 is now unclear.” On this news, the price of uniQure shares declined by $33.40 per share, or approximately 49.33%, from 67.69 per share on October 31, 2025 to close at $34.29 on November 3, 2025.
If you purchased or otherwise acquired uniQure securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.
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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Lauren Molinaro, Esq.

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Class Action Lawsuit

Frequently Asked Questions

What is the investigation against uniQure N.V. about?

The investigation concerns potential violations of federal securities laws by uniQure or its senior management.

What recent update did uniQure provide regarding AMT-130?

uniQure announced that the FDA may not view the Phase I/II AMT-130 data as sufficient for a BLA submission.

How did uniQure's stock price react to the news?

Following the news, uniQure shares fell by approximately 49.33%, dropping from $67.69 to $34.29.

Who can I contact for more information about the investigation?

You can contact Lauren Molinaro at Kirby McInerney LLP via email at investigations@kmllp.com.

Is there any cost to discuss rights regarding uniQure securities?

Discussing your rights or interests related to uniQure securities is at no cost.

Last updated: Nov 4, 2025