#United States #San Francisco #Hagens Berman #uniQure #FDA Criticism

Hagens Berman Intensifies Probe into uniQure Amidst FDA Fallout

In a major development that could impact many investors, Hagens Berman, a well-known shareholder rights law firm, has announced an update to its investigation concerning uniQure N.V. (NASDAQ: QURE). This comes on the heels of a significant public rebuke from the Food and Drug Administration (FDA) regarding uniQure's handling of its lead gene therapy candidate, AMT-130. With the April 13 deadline for stakeholders to act rapidly approaching, this situation warrants close attention.

The Background of the Investigation

Since the initiation of this probe, Hagens Berman has been scrutinizing claims surrounding uniQure and its interactions with regulatory authorities. The firm's investigation is particularly focused on alleged misrepresentations made by uniQure concerning its clinical practices and regulatory approvals, which, if substantiated, could significantly harm investors who bought shares during a specified time period.

The class action lawsuit filed against uniQure covers a timeline from September 24, 2025, to October 31, 2025. Investors who acquired uniQure's ordinary shares during this period and experienced financial losses may be eligible to be appointed as Lead Plaintiffs in the case.

A Closer Look at the FDA's Critique

The recent criticism from the FDA, reported by major media outlets like CNBC and The Wall Street Journal, paints a troubling picture for uniQure. An FDA official characterized AMT-130 as a “failed therapy,” accusing the company of conducting deceptive comparisons instead of adhering to established clinical study protocols. The official highlighted three key points during this media exposure:

1. Mischaracterization of Sham Surgeries: The FDA's official firmly rejected uniQure's ethical stance on sham surgeries, suggesting that the agency did not request extensive surgical procedures such as drilling holes in patients' skulls. Instead, they specified that minimally invasive procedures were acceptable.
2. Denial of Previous Agreements: The statement from the FDA directly countered claims made by uniQure's CEO that there had been a drastic change in the agency’s requirements, confirming that the agency had never agreed to the comparisons that uniQure purported to have validated.
3. Ineligibility for Pathways: The FDA noted that AMT-130 does not meet the qualification criteria for expedited regulatory pathways, as it is not considered an individualized treatment for rare diseases.

This sharp criticism from the FDA comes at a crucial time, as it has spurred Hagens Berman to re-evaluate its strategy regarding the securities class action filed on behalf of investors. Reed Kathrein, a leading partner at the firm, emphasized that uniQure may have maintained a pattern of misrepresenting its relationships with the FDA and utilizing a study design that was not sanctioned by the agency.

Allegations from the Class Action

The allegations outlined in the securities class action claim that uniQure failed to disclose several important facts during the Class Period:

• - Lack of Regulatory Consensus: It has been alleged that uniQure did not inform investors that the FDA had not approved the use of the ENROLL-HD external historical data set as a primary measure for AMT-130.
• - Hidden Requirements: Claims were made that the company downplayed the necessity of incorporating a sham-controlled surgery arm in its Phase III trials, which the FDA now insists was never waived.
• - Misleading Information on Application Timeline: Investors were allegedly misled regarding the timing of a Biologics License Application, leading to significant stock depreciation once the FDA's lack of agreement became public.

Call to Action for Investors

With the deadline of April 13, 2026, looming, investors who suffered losses during the specified time frame are urged to act promptly. There is a strong incentive to engage with Hagens Berman for more information on how to proceed regarding the ongoing investigation and potential involvement in the class action.

Hagens Berman has a long track record of successfully advocating for shareholders and whistleblowers, having, to date, recovered over $2.9 billion for those affected by corporate malfeasance.

For investors who possess non-public information about uniQure's operations or clinical practices, now is the time to consider reaching out to Hagens Berman or even the SEC's Whistleblower program. Effective contributions may yield significant rewards.

For more information and updates, visit Hagens Berman’s QURE Case Page.

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This story continues to unfold as new developments come to light. Stakeholders and observers alike remain vigilant as the consequences for uniQure become clearer amidst this regulatory storm.