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Hagens Berman Updates on uniQure's Legal Troubles

Amidst a backdrop of rising scrutiny, the national law firm Hagens Berman has announced updates on its investigation into uniQure N.V. (NASDAQ: QURE). This comes following compelling allegations from the Food and Drug Administration (FDA), which accused the biotechnology company of significant misconduct in its clinical trials, specifically regarding the gene therapy candidate AMT-130.

Allegations of Misconduct by FDA

Recent media coverage has spotlighted a tense exchange between FDA officials and uniQure, with reports discussing the FDA's serious concerns. An FDA representative called AMT-130 a "failed therapy," claiming uniQure was engaging in a "distorted or manipulated comparison" of its data rather than adhering to the correct clinical study protocols. This has raised a red flag among investors, especially those who might have acquired shares during the defined Class Period from September 24, 2025, to October 31, 2025.

The criticisms of uniQure’s methodology were stark, particularly in relation to the controversial sham surgeries required for clinical assessment. The FDA claimed that uniQure misrepresented the ethical considerations surrounding these surgeries, stating that their demands did not suggest invasive procedures such as "drilling holes in skulls," but rather minimal interventions under local anesthesia. This assertion raises significant ethical questions about how uniQure has portrayed its compliance to both stakeholders and the agency.

Timeline of Allegations

As major news outlets like The Wall Street Journal, CNBC, and CNN have reported, the clash has significant implications for uniQure’s ongoing research and business practices. Hagens Berman is particularly focused on the following key areas of concern:

• - Misrepresentation of Regulatory Agreement: Allegations indicate that uniQure has not disclosed crucial details about the FDA's stance on using historical data sets for control comparisons. This mischaracterization could indicate a fundamental misunderstanding—or intentional oversight—of regulatory requirements critical for the therapy’s approval.
• - Hidden Compliance Requirements: Investors are encouraged to understand that uniQure may have downplayed the importance of employing a sham-controlled surgical arm in their Phase III trials. The FDA's position suggests a lack of clarity on whether earlier waivers were granted for these protocols.
• - Misleading Timelines: There are claims that uniQure misled investors about the timing for submitting their Biologics License Application (BLA). The abrupt drop of 49% in stock value revealed on November 3, 2025, appears linked directly to investors learning of the FDA's counterclaims.

The Class Action Lawsuit

The firm is also reminding investors that the deadline for submitting a lead plaintiff application in the pending securities class action has been set for April 13, 2026. This class action lawsuit seeks to represent individuals who trustingly invested in uniQure during this critical period. The suit asserts that there is a consistent pattern of misrepresentation regarding the company’s interactions with the FDA. Legal representatives describe this as a pivotal struggle between investors' rights and corporate governance.

Hagens Berman urges any shareholders who have experienced financial losses due to uniQure's alleged mismanagement to take action. Those impacted can submit their accounts through the Hagens Berman website developed specifically for the uniQure case.

Looking Ahead

For potential whistleblowers, Hagens Berman offers a secure avenue to report any non-public information about uniQure, with incentives available under the SEC's Whistleblower program. This initiative encourages citizens to come forward with information that could shed further light on the issues surrounding uniQure.

The implications of these developments extend beyond individual shareholders as they underline the importance of transparency and ethical conduct in the biotechnology sector. As this situation evolves, stakeholders will undoubtedly be watching closely, and Hagens Berman continues to position itself as an advocate for investor rights amid corporate accountability.

For those interested in following the ongoing developments, Hagens Berman actively updates their findings on their official channels, reaffirming their commitment to corporate accountability within the biotech landscape. Interested parties can visit their website for continuous updates and further details on the class action lawsuit against uniQure.