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Hagens Berman's Investigation Update on uniQure

On April 5, 2026, Hagens Berman, a national law firm that specializes in shareholder rights, announced an update regarding its investigation into uniQure N.V. (NASDAQ: QURE). This comes on the heels of substantial criticism from the FDA directed at uniQure's gene therapy candidate and the filing of a securities class action lawsuit. Investors are reminded of the impending deadline of April 13, 2026, to act as lead plaintiffs in this growing legal matter.

Background of the Investigation

The investigation focuses on alleged claims of misrepresentation by uniQure during a critical period, specifically between September 24, 2025, and October 31, 2025. This class action aims to represent investors who acquired shares during this time, with significant revelations emerging from the FDA's recent criticisms of uniQure's research processes and ethical practices.

In a striking move, FDA officials described uniQure's lead gene therapy, AMT-130, as a "failed therapy." During a media call covered by major outlets such as The Wall Street Journal and CNBC, officials criticized uniQure's research methodology and its portrayal of ethical considerations surrounding its clinical studies.

Key Critiques from the FDA

1. Mischaracterization of Clinical Trials: The FDA took issue with uniQure's handling of ethical concerns related to sham surgeries employed in trials. An FDA spokesperson alleged that uniQure misrepresented regulatory requirements, stating that minimal incisions under anesthesia had been requested—not the drastic procedures suggested by uniQure's communications.
2. Disputed Regulatory Consensus: One of the core allegations claims that uniQure purportedly had prior agreements with the FDA that were denied outright in the recent probe. The FDA stated it never approved the comparison methodology uniQure employed, which included external historical data sets.
3. Eligibility Concerns: The FDA raised questions regarding AMT-130’s suitability for streamlined review pathways for rare diseases, citing that it is not an individualized treatment method as uniQure had purported.

Class Action Lawsuit Details

The securities class action, titled Scocco v. uniQure N.V., et al., alleges that throughout the class period, uniQure failed to disclose vital information about its interactions with the FDA. Investors are alleging:

• - There was no regulatory consensus on essential therapy parameters.
• - uniQure downplayed the considerable requirements surrounding its clinical trials, creating a narrative of ease where significant hurdles existed.
• - Misleading commentary regarding the timeline for a Biologics License Application (BLA) contributed to significant financial losses post-announcement of the FDA’s position.

According to Hagens Berman partner Reed Kathrein, the lawsuit highlights a continuous pattern of misrepresentation that has left investors vulnerable to significant losses, particularly following the dramatic 49% stock plunge when the FDA’s statements became public.

Act Before It’s Too Late

For those who acquired uniQure shares during the relevant period and sustained losses, Hagens Berman encourages prompt action. Investors have until April 13, 2026, to file for lead plaintiff status in the class action. Investigating this situation further may reveal greater repercussions for those involved, and potential damages could hinge on investor participation.

For any inquiries or to discuss submission of losses related to uniQure, interested parties can reach out to the law firm directly at 844-916-0895 or via email at [email protected].

The Importance of Holding Corporations Accountable

Hagens Berman has been a leader in corporate accountability, focusing on investor rights within the ever-evolving landscape of clinical trials and biotech industries. The firm's dedicated efforts have successfully secured more than $2.9 billion for clients affected by corporate negligence or misconduct.

As this situation unfolds, investors are urged to remain vigilant and informed. For continued updates on this case and to follow the developments as they arise, keep an eye on Hagens Berman’s dedicated QURE case page and their official communications.

Conclusion

The intersection of healthcare and investor rights is complex, and recent developments surrounding uniQure serve as a reminder of the importance of transparency in clinical research and the ethical implications therein. With the April deadline fast approaching, now is the time for investors to decide their course of action.