QURE INVESTOR ALERT: uniQure Faces Securities Class Action Over AMT-130 Clinical Trial Design - Hagens Berman

Hagens Berman Scrutinizing Alleged AMT-130 Clinical Trial Misstatements; April 13 Lead Plaintiff Deadline

SAN FRANCISCO, March 16, 2026 /PRNewswire/ -- Investor rights law firm Hagens Berman reminds investors in uniQure N.V. (NASDAQ: QURE) that the Lead Plaintiff Deadline in litigation against the company and certain of its executives is rapidly approaching: April 13, 2026.

The lawsuit alleges that the defendants made inaccurate and misleading statements regarding the regulatory path for its lead gene therapy candidate, AMT-130, specifically concerning the FDA's acceptance of a "pivotal" study design that omitted a traditional placebo control.

Hagens Berman is investigating the alleged claims that uniQure violated the federal securities laws.  The firm urges who purchased QURE securities during the Class Period and suffered significant losses to contact the firm now to discuss their rights.

Class Period: Sept. 24, 2025 – Oct. 31, 2025
Lead Plaintiff Deadline: Apr. 13, 2026
Visit: www.hbsslaw.com/investor-fraud/qure

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%.

"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," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation.

If you invested in uniQure and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now »

If you'd like more information and answers to additional frequently asked questions about the uniQure case and the firm's investigation, read more »

Whistleblowers: Persons with non-public information regarding uniQure should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC.

About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

SOURCE Hagens Berman Sobol Shapiro LLP