uniQure Investors Sue Company Over Huntington’s Disease Drug Study Claims

A class action lawsuit was filed against uniQure QURE -2.80% ▼ on February 10, 2026.

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Plaintiffs -investors- in the federal securities class action allege that they acquired uniQure stock at artificially inflated prices between September 24, 2025, and October 31, 2025, known as the “Class Period.” They are now seeking compensation for financial losses incurred upon public revelation of the company’s alleged misconduct during that time. To learn whether you may be eligible for a recovery under this securities lawsuit, click here.

What Does QURE Do?

• uniQure is a biotechnology company. It engages in the development of gene therapies for rare diseases. These include, but are not limited to, Huntington’s disease (“HD”), amyotrophic lateral sclerosis (“ALS”) caused by mutations in superoxide dismutase 1, refractory mesial temporal lobe epilepsy, and Fabry disease.

• As also detailed in the complaint, the company’s leading drug is AMT-130. This is a new gene therapy being developed to slow the progression of HD, an inherited, incurable, genetic disorder. In patients diagnosed with HD, nerve cells in the brain have broken down, resulting in difficulty moving and thinking, as well as some mental health issues. Although there are some drugs currently used to treat HD symptoms, an approved means for slowing or stopping the fatal disorder does not yet exist, according to the complaint.

• The company says its roots can be traced to 1998, when it was founded as Amsterdam Molecular Therapeutics Holding N.V. It began Phase 1-2 Clinical Trial of AMT-130 in HD in 2019.

Why are Investors Suing QURE?

The company and three of its senior officers, along with the lead investigator for uniQure’s Pivotal Study (the “Individual Defendants”) are now accused of deceiving investors by lying and withholding important information about uniQure’s business and operations during the Class Period.

In particular, they are accused of omitting truthful information about the design of its Pivotal Study, and ancillary issues, from SEC filings and related material. By knowingly or recklessly doing so, they allegedly caused uniQure stock to trade at artificially inflated prices during the time in question.

The truth came out November 3, 2025. That’s when the company 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, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission.”

Taking a Closer Look

As alleged, the company and/or Individual Defendants repeatedly made false and misleading public statements throughout the Class Period.

During an earnings call held at the beginning of the Class Period, for instance, the company’s CEO, an Individual Defendant, stated in relevant part: “[w]e believe th[at] AMT-130 has the potential to be the first treatment to truly modify the course of Huntington’s disease.”

During the same call, uniQure’s Chief Medical Officer, an Individual Defendant, added in relevant part: “[t]hese results suggest a slowing of neurodegeneration” and noted that “AMT-130 has remained generally well-tolerated with a manageable safety profile at both doses.”

On the same call, the lead investigator for uniQure’s Pivotal Study (an Individual Defendant) then  reiterated that these study results, as compared to the external ENROLL-HD historical study approved by the FDA  “indicate that AMT-130 could have a significant impact on slowing disease progression and offer the potential to improve and lengthen quality of life in HD patients.”

Finally, in a prospectus accompanying the company’s September 2025 Offering, it stated in relevant part: “[b]ased on interactions with the FDA, it was agreed that data from cohorts 1 and 2 in the Phase I/II clinical trials could be compared to a propensity score-matched external control derived from the Enroll-HD natural history data set, under a prespecified statistical analysis plan, which may serve as the primary basis for a BLA submission.”

Actions You May Take

If you have purchased the Company’s stock during the Class Period, you may join the class action as a lead plaintiff, remain a passive class member, or opt out of this litigation and pursue individual claims that may not be available to the class as a whole. To learn more about your options, click here.

The deadline to file for lead plaintiff in this class action is April 13, 2026.

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