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uniQure N.V. Securities Fraud Class Action Result of FDA Approval Delay and 49% Stock Decline - Investors may Contact Lewis Kahn, Esq, at Kahn Swick & Foti, LLC

Key Takeaway: uniQure N.V. is facing a securities fraud class action lawsuit linked to a significant delay in FDA approval for its lead drug candidate AMT-130. The lawsuit arises from allegations that the company failed to notify investors about inadequate data supporting its BLA submission. Following a disclosure on November 3, 2025, regarding these issues, the company's stock plummeted by over 49%. Investors have been notified that they can file lead plaintiff applications by April 13, 2026, to recover financial losses incurred during the affected period.

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CONCERNS & RISKS

  • uniQure faced a 49% decline in stock price due to FDA approval delays.
  • The company is now charged with failing to disclose material information to investors.
  • The timeline for the Biologics License Application submission for AMT-130 is unclear.

Full Press Release Details

NEW YORK and NEW ORLEANS, March 03, 2026 (GLOBE NEWSWIRE) -- Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors with substantial losses that they have until April 13, 2026 to file lead plaintiff applications in a securities class action lawsuit against uniQure N.V. (NasdaqGS: QURE) (“uniQure” or the “Company”), if they purchased or otherwise acquired the Company’s shares between September 24, 2025 and October 31, 2025, inclusive (the “Class Period”). This action is pending in the United States District Court for the Southern District of New York.
If you purchased shares of uniQure and would like to discuss your legal rights and how this case might affect you and your right to recover for your economic loss, you may, without obligation or cost to you, contact KSF Managing Partner Lewis Kahn toll-free at 1-877-515-1850 or via email (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nasdaqgs-qure/ to learn more. If you wish to serve as a lead plaintiff in this class action, you must petition the Court by April 13, 2026.
uniQure and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
During the Class Period, the Company represented to investors that there was a high likelihood that its leading drug candidate, AMT-130, would receive accelerated approval from the U.S. Food and Drug Administration (“FDA”) after the Company’s planned Biologics License Application (“BLA”) submission in the first quarter of 2026. However, on November 3, 2025, the Company disclosed that “the FDA currently no longer agrees that the 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” and as a result, “the timing of the BLA submission for AMT-130 is now unclear.”
On this news, the price of uniQure’s shares plummeted $33.40 per share, or more than 49%, from a close of $67.69 per share on October 31, 2025, to close at $34.29 per share on November 3, 2025.
The case is Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124.
About Kahn Swick & Foti, LLC
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation's premier boutique securities litigation law firms. This past year, KSF was ranked by SCAS among the top 10 firms nationally based upon total settlement value. KSF serves a variety of clients, including public and private institutional investors, and retail investors - in seeking recoveries for investment losses emanating from corporate fraud or malfeasance by publicly traded companies. KSF has offices in New York, Delaware, California, Louisiana, Chicago, and a representative office in Luxembourg.
TOP 10 Plaintiff Law Firms - According to ISS Securities Class Action Services
To learn more about KSF, you may visit www.ksfcounsel.com.
Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
1100 Poydras St., Suite 960
New Orleans, LA 70163
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Securities Litigation

Frequently Asked Questions

What is the deadline to file a lead plaintiff application?

Investors must file lead plaintiff applications by April 13, 2026.

What caused uniQure's stock price to drop?

The stock fell after news that the FDA questioned data adequacy for BLA submission.

Who can join the class action lawsuit?

Investors who purchased uniQure shares between September 24 and October 31, 2025, can join.

How can I contact Kahn Swick & Foti, LLC?

You can call toll-free at 1-877-515-1850 or email lewis.kahn@ksfcounsel.com.

What is the case name for the lawsuit against uniQure?

The case is named Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124.

Last updated: Mar 4, 2026