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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 stemming from delays in FDA approval for its drug candidate AMT-130. The lawsuit alleges that the company failed to disclose critical information regarding the likelihood of receiving accelerated approval for AMT-130. Following a significant announcement from the FDA questioning data adequacy from Phase I/II studies, uniQure's stock dropped over 49%, raising concerns among investors. The class action is pending in the Southern District of New York, with investors urged to act before April 13, 2026.

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CONCERNS & RISKS

  • uniQure faces a securities fraud class action due to failure in disclosing material information.
  • The FDA's decision on AMT-130 has led to an unclear timeline for its Biologics License Application.
  • Shares of uniQure plummeted over 49% following the announcement of the FDA's stance.

Full Press Release Details

NEW YORK and NEW ORLEANS, March 17, 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 lead plaintiff applications for uniQure?

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

What triggered the class action lawsuit against uniQure?

uniQure is accused of failing to disclose important information about its drug candidate.

How much did uniQure's stock drop on November 3, 2025?

The stock dropped $33.40 per share, over 49%, closing at $34.29.

Where is the class action against uniQure filed?

The lawsuit is pending in the Southern District of New York.

Who can investors contact regarding the class action?

Investors can reach KSF Managing Partner Lewis Kahn at 1-877-515-1850.

Last updated: Mar 18, 2026