uniQure N.V. (QURE) Securities Class Action

uniQure develops treatments for patients suffering from rare and other devastating diseases.  The complaint alleges that uniQure’s leading drug candidate is AMT-130, a novel gene therapy being developed to slow the progression of Huntington’s disease.

The complaint alleges that throughout the Class Period defendants misrepresented and failed to disclose that:

• 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 U.S. Food and Drug Administration (“FDA”); and
• Defendants downplayed the likelihood that, despite purportedly highly successful results from the AMT-130 Pivotal Study, uniQure would have to delay its Biologics License Application (“BLA”) timeline to perform additional studies to supplement its BLA submission.

The truth was allegedly revealed on November 3, 2025, when uniQure disclosed that the FDA “currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to [the ENROLL-HD] 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.” 

As a result, uniQure allegedly stated that “the timing of the BLA submission for AMT-130 is now unclear,” but that uniQure “plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of AMT-130.” 

On this news, the price of uniQure ordinary shares fell more than 49%.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the QURE investigation about?

The core of our investigation is the potential delta between what uniQure told investors about its interactions with the FDA and the details revealed in the recent Type A meeting minutes.

WHAT SHOULD I DO?

I worked at QURE. What should I do?

If you were an employee of QURE, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in QURE, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any QURE investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.