uniQure Faces Securities Fraud Class Action After FDA Approval Delay

Investors may contact Lewis Kahn, Esq. at Kahn Swick & Foti, LLC for more information

Published on Feb. 19, 2026

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uniQure N.V. is facing a securities fraud class action lawsuit after the company disclosed that the FDA no longer agreed its drug candidate AMT-130 data was adequate for a Biologics License Application submission, leading to a 49% stock decline. The lawsuit alleges uniQure failed to disclose material information during the class period from September 24, 2025 to October 31, 2025.

Why it matters

This case highlights the risks investors face when companies fail to properly disclose information that could impact their stock price. The significant stock decline following the FDA approval delay announcement underscores the importance of transparency from publicly traded pharmaceutical companies.

The details

The lawsuit alleges that during the class period, uniQure represented to investors that there was a high likelihood AMT-130 would receive accelerated FDA approval, but on November 3, 2025, the company disclosed the FDA no longer agreed the existing data was adequate to support a BLA submission, leading to a 49% stock plunge.

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

The players

uniQure N.V.

A biopharmaceutical company focused on developing gene therapies.

Kahn Swick & Foti, LLC

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

Lewis Kahn

The managing partner at Kahn Swick & Foti, LLC.

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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

Investors have until April 13, 2026 to file lead plaintiff applications in the securities class action lawsuit against uniQure.

The takeaway

This case highlights the importance of pharmaceutical companies being transparent with investors about potential regulatory risks and delays that could significantly impact their stock price. Investors will be closely watching how this lawsuit unfolds.