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Investigation Update on uniQure (QURE) by Hagens Berman

In a striking turn of events, Hagens Berman, a prominent national shareholder rights law firm, has reiterated its investigation into uniQure N.V. (NASDAQ: QURE) in light of some alarming feedback from the Food and Drug Administration (FDA). This comes after a securities class action lawsuit was launched to safeguard the interests of investors who acquired shares during a specified duration. The scrutiny follows serious allegations about uniQure’s gene therapy product, AMT-130, considered by the FDA to be a 'failed therapy'.

Background of the Case

The firm's investigation is rooted in a class action filed by investors who purchased uniQure's ordinary shares between September 24, 2025, and October 31, 2025. These investors may be significantly impacted as they are encouraged to act swiftly with an upcoming deadline set for April 13, 2026, to secure the position of Lead Plaintiff.

Revelations from FDA's Rebuke

On March 5-6, 2026, notable media outlets such as The Wall Street Journal and CNBC reported that during a call with the press, an FDA official issued a scathing critique of uniQure's clinical practices. The official accused uniQure of presenting a 'distorted comparison' regarding its clinical data against standard practices mandated by the FDA, thus raising significant concerns about the integrity of the trial data provided by the company. Here is a deeper dive into some essential revelations from the FDA’s statements:

Sham Surgery Miscommunication

The FDA official dismissed ethical concerns raised by uniQure regarding the implementation of sham surgeries, alleging the company has misinterpreted the agency's requests. Notably, instead of completely invasive procedures as claimed, it was clarified that the FDA merely asked for minor scalp nicks under local anesthesia.

Denial of Prior Consensus

Despite claims by uniQure’s CEO, Matt Kapusta, that the requirements were unexpectedly altered, the FDA confirmed no such previous agreement existed concerning the comparative analysis with untreated individuals.

Ineligibility for Streamlined Pathways

Another critical aspect discussed was the eligibility of AMT-130 for essential disease-targeted pathways, with the FDA stating it does not meet the qualification criteria.

Overview of Allegations in the Class Action

Key points concerning the securities class action involving uniQure detail various alleged failings by the company:

• - Lack of Regulatory Consensus: The FDA had not provided authorization for the utilization of external historical data as a primary control for AMT-130.
• - Concealed Obligations: uniQure purportedly minimized the need for a sham-controlled surgical arm for Phase III trials, a condition that the FDA insists was never waived.
• - Misleading Timelines: Investors were allegedly misinformed about the timeline for the Biologics License Application (BLA), particularly regarding the fallout from revelations made on November 3, 2025, which subsequently caused a staggering 49% decline in stock value.

Final Remarks and Call to Action

Investors who purchased shares during the aforementioned Class Period and faced financial losses are urged to act promptly, as the April 13 deadline looms for petitions to position as Lead Plaintiff in the ongoing litigation.

Hagens Berman encourages impacted shareholders to evaluate their standing and consider voicing their claims as part of this essential investigation. With the potential for significant financial recovery, early engagement is vital.

For further details on how to submit your QURE losses, contact Reed Kathrein at Hagens Berman at 844-916-0895 or visit their dedicated page for the case.

About Hagens Berman

Hagens Berman Sobol Shapiro LLP is a global law firm specializing in complex litigation aimed at corporate accountability. Representing a breadth of clients from investors to whistleblowers, the firm has a stellar record achieving over $2.9 billion in settlements and verdicts on behalf of those harmed by corporate wrongdoing.

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