Overview

A class action lawsuit has been filed against uniQure N.V. (“uniQure” or the “Company”) (NASDAQ : QURE), certain of the Company’s senior officers and collaborators (collectively, “Defendants”), alleging violations of the federal securities laws. The uniQure lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired uniQure securities between September 24, 2025, and October 31, 2025, inclusive (the “Class Period”). Investors have until April 13, 2026, to seek appointment as lead plaintiff of the uniQure class action lawsuit.

uniQure is a biotechnology company developing gene therapies for rare diseases, including Huntington’s disease (“HD”) and amyotrophic lateral sclerosis (“ALS”), among others.

The Company’s leading drug candidate is AMT-130, a novel gene therapy being developed to slow the progression of HD. In March 2022, uniQure completed patient enrollment for two 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”).

The complaint alleges that during the Class Period, Defendants assured investors that the U.S. Food and Drug Administration (“FDA”) agreed with the design of the Pivotal Study. Specifically, the FDA purportedly agreed with the Company’s plan that the Pivotal Study would not include any placebo comparator. Instead, the results could be compared to an external historical data set, known as Enroll-HD, and the analysis derived from such comparison 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.

However, in truth: (1) the design of uniQure’s Pivotal Study 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, Defendants’ statements about the Company’s business, operations, and prospects lacked a reasonable basis.

Investors learned the truth about the Company’s prospects and the BLA timeline for AMT-130 on November 3, 2025, when uniQure revealed 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 [Enroll-HD] … may be adequate to provide the primary evidence in support of a BLA submission.” The Company further stated that “the timing of the BLA submission for AMT-130 is now unclear.”

On this news, the price of uniQure stock plummeted $33.40 per share, or nearly 50%, from a close of $67.69 per share on October 31, 2025, to close at $34.29 per share on November 3, 2025.

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If you purchased or otherwise acquired uniQure securities between September 24, 2025, and October 31, 2025, and you wish to serve as lead plaintiff in this lawsuit, you are encouraged to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt attorneys Brian O’Mara and Hani Farah by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the uniQure class action lawsuit is April 13, 2026.