uniQure Sued Over Huntington's Drug Setback

Block & Leviton encourages investors who lost money to contact the firm

Published on Mar. 2, 2026

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A securities fraud lawsuit has been filed against uniQure N.V. (Nasdaq: QURE) and certain of its executives. The lawsuit alleges that the company misled investors about the strength of the clinical results and regulatory prospects for its AMT-130 gene therapy for Huntington's disease. Shares of uniQure fell over 35% on March 2, 2026, after the FDA said the clinical data was insufficient to support a marketing application and recommended the company conduct an additional study.

Why it matters

The lawsuit highlights the risks investors face when investing in biotech companies developing new therapies, as regulatory setbacks can lead to significant stock price declines. The case also raises questions about uniQure's disclosures and transparency with investors regarding the status of its Huntington's disease program.

The details

The securities class action lawsuit was filed in the U.S. District Court for the Southern District of New York. It alleges that uniQure and certain executives misled investors about the strength of the clinical results and the therapy's regulatory prospects during the period from September 24, 2025, through October 31, 2025. The lawsuit follows an earlier drop of as much as 66% in uniQure's stock price on November 3, 2025, when the company disclosed prior FDA feedback regarding the adequacy of its clinical data.

  • On March 2, 2026, shares of uniQure fell over 35% after the FDA said the clinical data supporting the company's AMT-130 gene therapy for Huntington's disease was insufficient.
  • On November 3, 2025, uniQure's stock price dropped as much as 66% when the company disclosed prior FDA feedback regarding the adequacy of its clinical data.
  • The class action lawsuit covers the period from September 24, 2025, through October 31, 2025.

The players

uniQure N.V.

A biopharmaceutical company developing gene therapies, including AMT-130 for Huntington's disease.

Block & Leviton

A securities class action law firm that has filed the lawsuit against uniQure and is encouraging investors who lost money to contact the firm.

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What’s next

The deadline to seek appointment as lead plaintiff in the lawsuit is April 13, 2026. Investors who purchased uniQure stock between September 24, 2025, and October 31, 2025 and have seen their shares fall may be eligible to participate in the case.

The takeaway

This lawsuit highlights the importance of biotech companies being transparent and accurate in their disclosures to investors, especially regarding the regulatory status of their drug candidates. Investors in the biotech sector need to be aware of the risks of clinical and regulatory setbacks that can significantly impact stock prices.