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uniQure Faces Legal Scrutiny Over AMT-130 Clinical Trial Misrepresentation

In a significant development for investors, uniQure N.V. (NASDAQ: QURE) is facing a securities class action lawsuit due to alleged misleading statements regarding its AMT-130 clinical trial design. The law firm Hagens Berman has indicated that the deadline for lead plaintiffs in this case is fast approaching on April 13, 2026. Investors who acquired shares during the class period from September 24, 2025, to October 31, 2025, and have endured substantial losses are being urged to seek legal counsel to determine their rights and possible claims.

Details of the Allegations

The crux of the lawsuit revolves around claims that uniQure made inaccurate representations regarding the regulatory approval processes associated with AMT-130, its foremost gene therapy candidate aimed at slowing the progression of Huntington's disease. It is alleged that the design of the pivotal study was not fully sanctioned by the FDA; a critical aspect since it purportedly skipped a traditional placebo control. This omission raises significant concerns about the integrity and robustness of the clinical trial data presented to investors.

Furthermore, the lawsuit asserts that uniQure downplayed the probability of delays to its Biologics License Application (BLA) timeline despite announcing favorable results. The firm contends there was a failure to disclose the necessity of additional studies that may affect the BLA submission process, suggesting that the company might have misled stakeholders regarding the study's compliance with FDA protocols.

The Turning Point

The situation escalated on November 3, 2025, when uniQure disclosed that the FDA no longer concurred that data from AMT-130’s early Phase I/II studies could support their BLA submission as claimed. The acute fallout was immediate, with shares of uniQure losing over 49% of their value following the announcement.

Reed Kathrein, a partner at Hagens Berman, highlighted that the firm's investigation is essential to uncover the discrepancies between uniQure’s communications to investors and the actual content discussed in FDA meetings. The legal ramifications could be severe for uniQure, emphasizing the need for transparency and accountability in the biotechnology sector, especially regarding communication of clinical trial results and regulatory assessments.

What Investors Should Do

Investors who realize they have substantial losses related to their uniQure stocks should reach out to legal professionals at Hagens Berman to learn more about their rights as shareholders. Additionally, the firm is also inviting whistleblowers with insider knowledge about uniQure to come forward, as they may be protected under the SEC Whistleblower program, potentially earning rewards up to 30% of any recovery achieved.

About Hagens Berman

Hagens Berman is a renowned complex litigation firm that fights for the rights of investors and consumers. They have a record of achieving significant results, securing over $2.9 billion for clients across various cases, emphasizing corporate accountability. Investors looking for more information on the uniQure case can visit their dedicated page and stay updated through the firm's social media channels.

In summary, uniQure's legal troubles over the AMT-130 trial design exemplify the ongoing challenges faced by biotechnology companies in maintaining trust with investors while navigating complex regulatory landscapes. Investors are encouraged to remain vigilant and informed as developments unfold in this critical court case.