SAN FRANCISCO, April 5, 2026 /PRNewswire/ — National shareholder rights law firm Hagens Berman is updating its investigation into uniQure N.V. (NASDAQ: QURE) a series of extraordinary rebukes by Food and Drug Administration (FDA) 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”). The firm reminds investors of the April 13, 2026, Lead Plaintiff deadline in the pending securities class action.
SUBMIT YOUR QURE LOSSES TO HBSS NOW
DEEP DIVE ANALYIS: Visit Hagens Berman’s dedicated QURE case page: www.hbsslaw.com/cases/uniqure, or view our latest video summary of the allegations: https://youtu.be/VWKl1BzabcE
The FDA Clash: “A Distorted or Manipulated Comparison”
On March 5 and 6, 2026, media outlets including The Wall Street Journal, CNBC, and CNN reported on a call with reporters where an FDA official lashed out at uniQure.
The official reportedly called uniQure’s lead gene therapy candidate, AMT-130, a “failed therapy,” alleging that the company is “performing a distorted or manipulated comparison in the mind of FDA” instead of running a correct clinical study.
Key revelations from the March 6 disclosure include:
- Sham Surgery Mischaracterization: The FDA official dismissed uniQure’s ethical concerns regarding sham surgeries, accusing the company of mischaracterizing the agency’s request. The official clarified that the FDA did not ask to “drill holes in skulls,” but rather required “one to three nicks in the scalp” under minimal anesthesia.
- Denial of Prior Agreement: While uniQure CEO Matt Kapusta described the sham surgery requirement as a “drastic change” from previous guidance, the FDA official pushed back, stating the agency “never agreed to accept this distorted comparison” using natural history as a comparator.
- Ineligibility for “Plausible Mechanism” Pathway: The official disputed AMT-130’s eligibility for streamlined rare-disease pathways, noting it is not an individualized treatment.
The recent reports follow the filing of a securities class action suit.
Investors in uniQure (QURE) are encouraged to visit the Hagens Berman QURE Case Page to review the allegations in the pending litigation: www.hbsslaw.com/cases/uniqure
“The pending securities class action alleges a consistent pattern: that uniQure misrepresented its interactions with the FDA and used a pivotal study design that it knew the agency had not approved,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation of the alleged claim in the pending litigation.
Summary of QURE Class Action Allegations: The “Pivotal” Study Mirage
The securities class action, Scocco v. uniQure N.V., et al. (S.D.N.Y.), alleges that throughout the Class Period (Sept. 24, 2025 – Oct. 31, 2025), defendants failed to disclose:
- No Regulatory Consensus: That the FDA had not approved the use of the ENROLL-HD external historical data set as a primary control for AMT-130.
- Hidden Requirements: That uniQure downplayed the necessity of a sham-controlled surgery arm for Phase III—a requirement the FDA now claims was never waived.
- Timeline Deception: That defendants misled investors regarding the timing of a Biologics License Application (BLA), which was rendered “unclear” once the lack of FDA agreement was revealed on November 3, 2025, sending the stock down 49%.
Critical Deadline: April 13, 2026
If you purchased uniQure ordinary shares during the Class Period (Sept. 24, 2025 – Oct. 31, 2025) and suffered losses, you have until April 13, 2026, to ask the Court to appoint you as Lead Plaintiff.
- Submit Your QURE Losses to HBSS Now
- Contact: Reed Kathrein at 844-916-0895 or email QURE@hbsslaw.com
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.
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SOURCE Hagens Berman Sobol Shapiro LLP
