uniQure N.V. (NASDAQ: QURE) Securities Fraud Class Action

Case Background:
This is a federal securities fraud class action lawsuit on behalf of those who purchased or otherwise acquired uniQure N.V. (“uniQure”) (NASDAQ: QURE) ordinary shares between September 24, 2025 and October 31, 2025, inclusive (the “Class Period”).

uniQure is a biotechnology company developing gene therapies for rare diseases, including Huntington’s disease (“HD”). The company’s leading drug candidate is AMT-130, a novel gene therapy being developed to slow the progression of HD, a usually fatal, inherited genetic disorder that causes nerve cells in the brain to break down, leading to problems with movement and thinking, as well as psychiatric issues. In March 2022, uniQure completed patient enrollment for two, ongoing multi-center, dose-escalating Phase I/II clinical trials for AMT-130 called the Pivotal Phase I/II Study of AMT-130 in patients with HD (the “Pivotal Study”).

According to the Defendants, the U.S. Food and Drug Administration (“FDA”) previously agreed that uniQure’s Pivotal Study would not include any placebo comparator, but instead, the Pivotal Study results could be compared to an external historical data set, known as Enroll-HD or ENROLL-HD, and the analysis derived from such comparison potentially could serve as the basis for uniQure’s Biologics License Application (“BLA”) submission to the FDA for approval to use AMT-130 to treat patients with HD.

The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the company’s business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) the design of uniQure’s Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; (2) Defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its BLA timeline to perform additional studies to supplement its BLA submission; and (3) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

Current Status of Case:
On August 12, 2026, Lead Plaintiff filed the Second Amended Complaint. This action is ongoing.

If you wish to discuss this action or have any questions, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at [email protected]. If you would like additional information about the suit, please click on the link “Submit Your Information” above and fill out the form as promptly as possible.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs’ Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent.