Investors Face a Legal Challenge as uniQure N.V. is Sued for Securities Fraud

Investor Alert: uniQure N.V. Faces Securities Fraud Class Action

Kessler Topaz Meltzer & Check, LLP has initiated a securities fraud class action lawsuit against uniQure N.V. (NASDAQ QURE), highlighting significant concerns for investors who acquired shares between September 24, 2025, and October 31, 2025. Investors might be eligible to participate in a lead plaintiff process to represent the class.

Background on uniQure N.V.

uniQure, a biotechnology company based in Amsterdam, focuses on developing gene therapies for rare diseases. Among their notable projects is AMT-130, designed to treat Huntington’s disease (HD), a severe neurodegenerative condition without a known cure. The expectation was that AMT-130 could significantly inhibit the disease's progression.

The legal action, designated Scocco v. uniQure N.V., et al., is underway in the U.S. District Court for the Southern District of New York. Investors claim that uniQure misled the market regarding its trials and subsequent potential regulatory approval from the FDA.

Timeline of Events

On September 24, 2025, uniQure released topline results from its pivotal study that suggested a promising performance of AMT-130 in reducing neurodegeneration biomarkers in HD patients. The company's leadership, including CEO Matthew Kapusta, received significant investor interest, leading to a notable surge in share prices—from $13.66 to $47.50 within a day, an astronomical jump of nearly 250%.

This spike allowed uniQure to conduct a public offering shortly after, generating about $345 million in proceeds, aimed at funding activities related to commercializing AMT-130.

However, doubts about the study's validity arose. On November 3, 2025, uniQure admitted that the FDA was reluctant to accept the trial data for approval, stating that their pre-specified study design was not adequately approved for regulatory submission. This revelation caused a significant downturn, with share prices dropping by over 49% shortly after, from a close of $67.69 to $34.29.

Allegations of Fraud

The allegations against uniQure include:
1. Misrepresentation of Study Approvals: The company allegedly did not have full FDA approval for the pivotal study design, leading to claims that the results were misleading.
2. Unrealistic Assumptions About Approval: Executive statements regarding the likelihood of receiving expedited FDA approval were based on assumptions that later proved unfounded.
3. Lack of Disclosure: The firm failed to disclose critical facts that could affect investor decisions, thereby misleading stakeholders about the company’s performance and prospects.

Investor Action

Investors who suffered losses are urged to act quickly, as the deadline to seek lead plaintiff status is April 13, 2026. Being a lead plaintiff involves guiding the direction of the litigation and can help secure a more favorable outcome for those affected.

For those looking to pursue this avenue, contacting Kessler Topaz Meltzer & Check, LLP is encouraged. This action aims to protect the rights and interests of investors who made decisions based on misleading information.

About Kessler Topaz Meltzer & Check, LLP

Kessler Topaz Meltzer & Check is a premier law firm specializing in securities fraud cases, known for its strong track record in representing investors. The firm encourages affected uniQure shareholders to consult for deeper insights into participating in the class action lawsuit and securing their rights. More information can be found through their official website.

Contact:
Jonathan Naji, Esq.
Kessler Topaz Meltzer & Check, LLP
280 King of Prussia Road
Radnor, PA 19087
Email
(484) 270-1453

This case serves as a critical reminder for investors to remain vigilant about the information provided by biotechnology firms, especially those involved in high-stakes clinical trials. As the legal proceedings unfold, it will be essential for investors to stay informed and engaged.