uniQure Faces Legal Scrutiny After Allegations of Regulatory Misconduct
In a significant development for investors and stakeholders alike, national shareholder rights law firm Hagens Berman has provided an update on its ongoing investigation into uniQure N.V. (NASDAQ: QURE). This announcement comes in the wake of striking criticisms from the U.S. Food and Drug Administration (FDA) regarding the company's developmental gene therapy candidate, AMT-130. The FDA's critical stance has raised questions about uniQure's practices and has led to a pending securities class action lawsuit for investors who acquired shares during a specified period.
On March 5 and 6, 2026, reputable media outlets such as The Wall Street Journal, CNBC, and CNN reported on a media call where an FDA official did not hold back in expressing dissatisfaction with uniQure’s actions. The official branded AMT-130 as a 'failed therapy' and accused the company of 'performing a distorted or manipulated comparison' that misled both regulators and investors.
This report disclosed alarming details about the FDA's views, including a disregard for uniQure's ethical claims concerning sham surgeries, which were depicted as more invasive than required. The FDA maintained that its request was only for 'one to three nicks in the scalp' under minimal anesthesia, highlighting a miscommunication about what was expected from the trials.
Furthermore, uniQure's CEO, Matt Kapusta, previously asserted that the requirement for sham surgeries represented a significant shift from prior guidance. However, the FDA official rebuffed this claim, stressing that there had never been an agreement to accept what uniQure portrayed as a 'distorted comparison.' This contention raises substantial concerns regarding the transparency of uniQure's reporting to both regulators and investors, particularly in how it characterized its regulatory interactions.
The allegations extend to uniQure's attempts to qualify AMT-130 under streamlined regulatory pathways. The FDA official asserted that AMT-130 is not an individualized treatment necessary to benefit from such avenues, pushing back against the narrative created by uniQure that it was positioned to be a breakthrough therapy.
The backdrop of this legal turmoil further highlights the securities class action suit, Scocco v. uniQure N.V., et al. (S.D.N.Y.). The lawsuit claims that throughout the class period from September 24 to October 31, 2025, uniQure withheld critical information from shareholders, including:
1. Lack of Regulatory Consensus: The FDA had not approved the use of external historical data as a primary control for AMT-130.
2. Hidden Requirements: The necessity for a sham-controlled surgery arm in Phase III trials was downplayed, despite it being a requirement that the FDA did not waive.
3. Timeline Deception: The company allegedly misled investors regarding the timing of its Biologics License Application, particularly after the lack of agreement from the FDA led to a staggering 49% drop in stock value.
As investors weigh their options, it is essential to acknowledge that the clock is ticking. Hagens Berman has alerted shareowners that the deadline to appoint a Lead Plaintiff is set for April 13, 2026. Those who invested in uniQure during the specified timeframe and experienced losses are encouraged to act promptly and consider seeking legal advice.
In light of these developments, the firm is also calling for whistleblowers with non-public information regarding uniQure's operations to consider their options, potentially benefiting from the SEC Whistleblower Program, which can reward up to 30% of recovery amounts.
Hagens Berman is known for its dedication to corporate accountability and has successfully represented various stakeholders seeking justice against corporate malfeasance. The firm continues to monitor this evolving situation closely and advocates for investors' rights as this case unfolds.
On March 5 and 6, 2026, reputable media outlets such as The Wall Street Journal, CNBC, and CNN reported on a media call where an FDA official did not hold back in expressing dissatisfaction with uniQure’s actions. The official branded AMT-130 as a 'failed therapy' and accused the company of 'performing a distorted or manipulated comparison' that misled both regulators and investors.
This report disclosed alarming details about the FDA's views, including a disregard for uniQure's ethical claims concerning sham surgeries, which were depicted as more invasive than required. The FDA maintained that its request was only for 'one to three nicks in the scalp' under minimal anesthesia, highlighting a miscommunication about what was expected from the trials.
Furthermore, uniQure's CEO, Matt Kapusta, previously asserted that the requirement for sham surgeries represented a significant shift from prior guidance. However, the FDA official rebuffed this claim, stressing that there had never been an agreement to accept what uniQure portrayed as a 'distorted comparison.' This contention raises substantial concerns regarding the transparency of uniQure's reporting to both regulators and investors, particularly in how it characterized its regulatory interactions.
The allegations extend to uniQure's attempts to qualify AMT-130 under streamlined regulatory pathways. The FDA official asserted that AMT-130 is not an individualized treatment necessary to benefit from such avenues, pushing back against the narrative created by uniQure that it was positioned to be a breakthrough therapy.
The backdrop of this legal turmoil further highlights the securities class action suit, Scocco v. uniQure N.V., et al. (S.D.N.Y.). The lawsuit claims that throughout the class period from September 24 to October 31, 2025, uniQure withheld critical information from shareholders, including:
1. Lack of Regulatory Consensus: The FDA had not approved the use of external historical data as a primary control for AMT-130.
2. Hidden Requirements: The necessity for a sham-controlled surgery arm in Phase III trials was downplayed, despite it being a requirement that the FDA did not waive.
3. Timeline Deception: The company allegedly misled investors regarding the timing of its Biologics License Application, particularly after the lack of agreement from the FDA led to a staggering 49% drop in stock value.
As investors weigh their options, it is essential to acknowledge that the clock is ticking. Hagens Berman has alerted shareowners that the deadline to appoint a Lead Plaintiff is set for April 13, 2026. Those who invested in uniQure during the specified timeframe and experienced losses are encouraged to act promptly and consider seeking legal advice.
In light of these developments, the firm is also calling for whistleblowers with non-public information regarding uniQure's operations to consider their options, potentially benefiting from the SEC Whistleblower Program, which can reward up to 30% of recovery amounts.
Hagens Berman is known for its dedication to corporate accountability and has successfully represented various stakeholders seeking justice against corporate malfeasance. The firm continues to monitor this evolving situation closely and advocates for investors' rights as this case unfolds.
Topics Financial Services & Investing）
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