QURE ALERT: FDA Reportedly Accuses uniQure of Pushing “Distorted” and “Manipulated” Data For “Failed” AMT-130 Drug Amid Pending Securities Class Action – Hagens Berman

SAN FRANCISCO, March 11, 2026 (GLOBE NEWSWIRE) -- National shareholder rights law firm Hagens Berman is updating its investigation into uniQure N.V. (NASDAQ: QURE) following an unprecedented public rebuke of the company by federal health officials. This investigation follows the filing of a securities class action lawsuit seeking to represent investors who purchased or otherwise acquired uniQure ordinary shares between September 24, 2025, and October 31, 2025 (the “Class Period”).

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Federal Officials Condemn uniQure in WSJ Report: “Company Lied”

On March 5, 2026, The Wall Street Journal published “Federal Health Officials Attack Rare-Disease Drug, Say Company Lied,” reporting on unusual public criticism by officials at the Food and Drug Administration and Department of Health and Human Resources directed at uniQure N.V. (NASDAQ: QURE).

According to the report, “[a] senior FDA official said in a call with reporters Thursday that the data from the testing of Uniqure’s gene therapy were flawed and signaled the drug candidate didn’t meet the bar for agency approval.” The therapy at issue is uniQure’s lead gene therapy candidate, AMT-130, which is being developed to slow the progression of Huntington’s disease.

Worse, the WSJ reported “[t]he official also said a Uniqure executive had mischaracterized the FDA’s request for how to compare the therapy to a placebo[]” and “[a]n HHS official said the company had ‘lied’ and put out misleading statements.”

The next day, STAT reported “[w]hat started months ago as a scientific disagreement between the FDA and UniQure over how best to study a gene therapy for Huntington’s disease metastasized on Thursday into a diatribe by the senior FDA official, who accused UniQure of pushing ‘distorted’ and ‘manipulated’ clinical data for a ‘failed’ therapy.”

The reports follow a series of devastating reports, beginning November 3, 2025, that have driven the price of uniQure shares down nearly 84% by the time of the WSJ publication, and the filing of a securities class action lawsuit.

The uniQure N.V. (QURE) Securities Class Action: Key Details

Summary of Allegations: The “Pivitol” Study Mirage

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. For more information, call Reed Kathrein at 844-916-0895 or email QURE@hbslaw.com.

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.

Contact:
Reed Kathrein, 844-916-0895

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