uniQure Faces Securities Fraud Lawsuit After FDA Approval Delay

Investors may contact Lewis Kahn, Esq. at Kahn Swick & Foti, LLC to discuss legal rights and potential recovery.

Mar. 25, 2026 at 3:51am

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uniQure N.V. is facing a securities fraud class action lawsuit in the United States District Court for the Southern District of New York. The lawsuit alleges that the company and certain executives failed to disclose material information during the class period from September 24, 2025 to October 31, 2025, violating federal securities laws. The lawsuit was filed after uniQure disclosed that the FDA no longer agreed its data was adequate to support a Biologics License Application (BLA) submission for its lead drug candidate AMT-130, causing the stock price to plummet 49%.

Why it matters

This case highlights the importance of transparency and accurate disclosures by publicly traded pharmaceutical companies, especially regarding the regulatory approval process for their drug candidates. Investors rely on this information to make informed decisions, and any failure to disclose material facts can lead to significant losses.

The details

According to the lawsuit, uniQure represented to investors that there was a high likelihood AMT-130 would receive accelerated FDA approval after the company's planned BLA submission in Q1 2026. However, on November 3, 2025, uniQure disclosed that the FDA no longer agreed the data from the Phase I/II studies was adequate to support the BLA, and the timing of the submission was now unclear. This news caused uniQure's stock price to plummet over 49% in a single day.

  • The class period is from September 24, 2025 to October 31, 2025.
  • Investors have until April 13, 2026 to file lead plaintiff applications in the lawsuit.

The players

uniQure N.V.

A biopharmaceutical company focused on developing gene therapies for rare genetic disorders.

Kahn Swick & Foti, LLC

A securities litigation law firm representing public and private institutional investors, as well as retail investors, in seeking recoveries for investment losses.

Lewis Kahn

Managing Partner at Kahn Swick & Foti, LLC.

Charles C. Foti, Jr.

Partner at Kahn Swick & Foti, LLC and former Attorney General of Louisiana.

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What they’re saying

“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.”

— Lewis Kahn, Managing Partner, Kahn Swick & Foti, LLC

What’s next

The judge in the case will decide on April 13, 2026 whether to allow the lawsuit to proceed as a class action.

The takeaway

This case underscores the need for pharmaceutical companies to be fully transparent with investors about the regulatory status of their drug candidates. Failure to disclose material information can lead to significant losses for investors and erode public trust in the industry.