#USA #San Francisco #FDA #Securities Class Action #uniQure

Hagens Berman's Detailed Investigation into uniQure N.V.

Hagens Berman, a prominent law firm focused on shareholder rights, is intensifying its investigation concerning uniQure N.V. (NASDAQ: QURE). This comes in light of recent allegations aimed at the company by the Food and Drug Administration (FDA), raising critical questions about uniQure’s clinical practices and data integrity.

In March 2026, during a media call, a high-ranking FDA official accused uniQure of not only misrepresenting its lead gene therapy candidate, AMT-130, but also of running clinical studies that were potentially flawed. The official described AMT-130 as a “failed therapy” and labeled the company’s approach to data comparison as a “distorted or manipulated” perspective.

The FDA's scrutiny points to several crucial issues raised during this confrontation:

1. Mischaracterization of Sham Surgery: The FDA spokesperson highlighted that the ethical concerns presented by uniQure regarding sham surgeries were misguided. They clarified that the FDA had not requested invasive procedures but instead suggested minimal interventions such as “one to three nicks in the scalp” under light anesthesia.

2. Contest of Prior Agreements: uniQure's CEO, Matt Kapusta, claimed that recent requirements for sham surgery represented a deviation from prior guidance. In response, the FDA refuted this by emphasizing that they did not endorse the comparative methods uniQure employed in its submissions.

3. Plausibility of Treatment Pathways: The FDA explicitly stated that AMT-130 did not qualify for any accelerated treatment pathways typically reserved for rare diseases, indicating a significant hurdle for the drug’s approval status.

The aforementioned revelations have surfaced amid the current class action lawsuit, where investors litigation alleges that uniQure consistently misled them regarding essential data concerning FDA interactions. This legal action, which covers untruths about regulatory agreements and study designs, highlights a pattern of alleged deception that has left investors wary of the company's future.

Key Allegations from the Class Action Lawsuit

The lawsuit filed against uniQure presents several alarming claims:

• - Lack of Regulatory Consensus: The FDA never validated uniQure’s use of the ENROLL-HD external historical dataset as a control for AMT-130, an assertion uniQure purportedly concealed from their investors.
• - Downplaying Surgery Arm Necessity: The suit argues that uniQure obscured the FDA’s requirement for a sham-controlled surgery component in Phase III clinical trials, which may have been an essential component of the study design the company pursued.
• - Misleading Timeline of BLA Submission: The lawsuit maintains that defendants led investors to believe the timeline for submitting a Biologics License Application (BLA) was clear. However, after the revelation of the FDA’s lack of agreement on critical design aspects, the stock plummeted by 49%.

Drawing Attention to Critical Deadlines

Investors who purchased uniQure shares between September 24, 2025, and October 31, 2025, are reminded of a critical deadline looming on April 13, 2026. This deadline allows affected shareholders the opportunity to request the appointment of a Lead Plaintiff in the ongoing class action suit.

Should your investments align with this timeframe, now is the moment to submit losses directly to Hagens Berman to ensure rights are protected and voices heard. Those with information that can bolster the investigation are encouraged to reach out as whistleblower protections may also provide substantial rewards.

Conclusion

As this case develops, Hagens Berman remains dedicated to pursuing justice and accountability on behalf of shareholders affected by uniQure's conduct. Potential investors are advised to remain vigilant and to consider the implications these allegations hold for the company’s future, especially in light of the ongoing uncertainty surrounding its flagship therapy, AMT-130.