Robbins LLP Reminds Investors of Class Action Against uniQure N.V.

Lawsuit alleges biotech company misled investors about likelihood of FDA approval for leading drug candidate

Published on Feb. 14, 2026

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Robbins LLP has filed a class action lawsuit on behalf of investors who purchased uniQure N.V. (NASDAQ: QURE) ordinary shares between September 24, 2025 and October 31, 2025. The lawsuit alleges that uniQure failed to disclose that the design of its Pivotal Study for its leading drug candidate AMT-130 was not fully approved by the FDA, and that the company downplayed the likelihood it would have to delay its Biologics License Application (BLA) submission to perform additional studies.

Why it matters

The lawsuit highlights the risks investors face when biotech companies allegedly provide misleading information about the regulatory approval process for their drug candidates. Investors rely on accurate disclosures to make informed decisions, and lawsuits like this aim to hold companies accountable for any alleged deception.

The details

According to the complaint, uniQure announced on November 3, 2025 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 group "may be adequate to provide the primary evidence in support of a BLA submission." This news caused uniQure's stock price to plummet more than 49% in a single day.

  • The class action was filed on behalf of investors who purchased uniQure shares between September 24, 2025 and October 31, 2025.
  • On November 3, 2025, uniQure announced the FDA's feedback on the AMT-130 Pivotal Study design.

The players

uniQure N.V.

A biotechnology company developing gene therapies for rare diseases.

Robbins LLP

A law firm representing the plaintiffs in the class action lawsuit against uniQure.

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What they’re saying

“Robbins LLP reminds stockholders that a class action was filed on behalf of all investors who purchased or otherwise acquired uniQure N.V. (NASDAQ: QURE) ordinary shares between September 24, 2025 and October 31, 2025.”

— Robbins LLP (PRNewswire)

What’s next

Shareholders who wish to serve as lead plaintiff for the class must submit their papers to the court by April 13, 2026.

The takeaway

This case underscores the importance of biotech companies providing full and accurate disclosures to investors about the regulatory approval process for their drug candidates. Lawsuits like this aim to hold companies accountable and protect investor interests when alleged deception occurs.