uniQure N.V. Class Action Lawsuit - QURE
Case Summary
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The uniQure class action lawsuit seeks to represent purchasers or acquirers of uniQure N.V. (NASDAQ: QURE) ordinary shares between September 24, 2025 and October 31, 2025, inclusive (the “Class Period”). Captioned Scocco v. uniQure N.V., No. 26-cv-01124 (S.D.N.Y.), the uniQure class action lawsuit charges uniQure, certain of uniQure’s top executives, and the lead investigator of uniQure’s Phase I/II clinical trials for AMT-130 with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the uniQure class action lawsuit, please provide your information in the form on this page. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the uniQure class action lawsuit must be filed with the court no later than April 13, 2026.
CASE ALLEGATIONS: 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 uniQure class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) 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 (ii) 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 uniQure class action lawsuit further alleges that on November 3, 2025, uniQure revealed 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%, according to the complaint.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired uniQure ordinary shares during the Class Period to seek appointment as lead plaintiff in the uniQure class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the uniQure investor class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the uniQure shareholder class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the uniQure class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig.