uniQure N.V. Class Action Lawsuit – QURE
Introduction to uniQure N.V. (QURE) Securities Class Action Lawsuit
A securities fraud class action under the Securities Exchange Act of 1934 has been filed against uniQure N.V. (NASDAQ: QURE) covering investors who bought ordinary shares from September 24, 2025 through October 31, 2025. Investors allege the company and senior executives told the market the FDA agreed with key parts of the AMT-130 pivotal program and downplayed the risk of delays to a Biologics License Application (BLA) and the accelerated approval pathway. The story unraveled when, in November and December 2025, uniQure disclosed the FDA no longer agreed that AMT-130 Phase I/II data compared to a control from the ENROLL-HD external historical dataset could provide the primary evidence for a BLA and admitted the BLA timing was unclear. The market reaction was swift: after soaring on September 24, 2025, shares later fell $33.40 (49.33%) on November 3, 2025. According to the complaint, investors suffered significant losses as shares traded at artificially inflated prices during the Class Period when the truth surfaced.
“Most QURE shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.
uniQure N.V. (QURE) Securities Lawsuit Case Details
Case Name: Scocco v. uniQure N.V. et al.
Case No.: 1:26-cv-01124
Jurisdiction: U.S. District Court, Southern District of New York
Filed on: February 10, 2026
uniQure N.V. (QURE) Company Profile
uniQure is a biotechnology company headquartered in Amsterdam, The Netherlands, and publicly traded on the NASDAQ exchange developing gene therapies for rare diseases, including Huntington's disease, amyotrophic lateral sclerosis caused by SOD1 mutations, refractory mesial temporal lobe epilepsy, and Fabry disease. Its leading drug candidate is AMT-130, a novel gene therapy being developed to slow the progression of Huntington's disease, currently in Phase I/II clinical trials.
uniQure N.V. (QURE) Securities Lawsuit Class Period
September 24, 2025-October 31, 2025, inclusive (38 days).
All persons and entities who purchased or otherwise acquired uniQure (NASDAQ: QURE) ordinary shares during the Class Period may be eligible to join the uniQure N.V. (QURE) class action lawsuit.
Allegations in the uniQure N.V. (QURE) Securities Class Action Lawsuit
The lawsuit targets uniQure N.V. and four individuals: Chief Executive Officer Matthew Kapusta, Chief Financial Officer Christian Klemt, Chief Medical Officer Walid Abi-Saab, and lead investigator Sarah Tabrizi, alleging violations of the Securities Exchange Act of 1934 and Rule 10b-5.
According to the complaint, they presented AMT-130's pivotal program as aligned with FDA expectations and suggested the company had clear, supportive regulatory feedback, setting the stage for a BLA based on comparisons to an external control dataset from ENROLL-HD and, during the Class Period, conducted a September 25, 2025 stock offering of 5.7 million ordinary shares and 500,000 pre-funded warrants that generated approximately $345 million in proceeds including a potential accelerated approval pathway.
The narrative begins months before the class period.
On June 2, 2025, Kapusta told investors the FDA had agreed that the primary efficacy analysis would compare three-year cUHDRS changes between high-dose AMT-130 patients and an adjusted using propensity score matching methodology control group from the ENROLL-HD database , an external historical control dataset. Then on July 29, 2025, he said on the second quarter earnings call that "all of our interactions with the FDA have been very encouraging and very supportive" and that the company had "very clear and unambiguous feedback" from the agency.
As the class period opened on September 24, 2025, the company amplified these themes. At an investor conference that day, Kapusta said, "we believe these findings provide compelling and clinically meaningful evidence of AMT-130 disease modifying potential," while Abi-Saab stated the FDA agreed cUHDRS could serve as an acceptable registrational, intermediate clinical endpoint for accelerated approval and that ENROLL-HD may be acceptable as the external control dataset matched on baseline characteristics.
Behind these statements, investors allege a different reality. The complaint asserts the pivotal study design-including comparison to ENROLL-HD-was not fully approved by the FDA, and defendants downplayed the likelihood that uniQure would have to delay its BLA timeline to conduct additional studies. As a result, the complaint alleges that statements about the company's business, operations, and prospects lacked a reasonable basis, artificially inflating the stock price during the Class Period.
The Truth Emerges
The picture shifted after the class period closed. On November 3, 2025, uniQure announced the "FDA currently no longer agrees that the data from the Phase I/II studies of AMT-130 in comparison to an external control... may be adequate to provide the primary evidence in support of a BLA submission," and management acknowledged "the timing of the BLA submission for AMT-130 is now unclear," displacing the previously discussed plan for a Q1 2026 BLA submission.
A week later, on November 10, 2025, Abi-Saab said the FDA's recent feedback "has introduced uncertainty into the path forward," including the feasibility of an accelerated approval pathway based on external control comparisons.
The company followed with a December 4, 2025 confirmation that "the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission," underscoring the U.S. Food and Drug Administration's view that the ENROLL-HD external control could not serve as primary evidence. These disclosures directly contradicted prior assurances about FDA agreement on study design, use of ENROLL-HD as an external control for the primary analysis, and the implied BLA timeline.
Market Reaction
The market first responded to the company's September 24, 2025 messaging. After uniQure announced topline results of the Pivotal Study that day, the stock jumped from a close of $13.66 per share on September 23 to close at $47.50 on September 24, a nearly 250% increase, on the NASDAQ market, and by October 29, 2025, shares were trading above $70.00 per share, closing at $67.69 on October 31.
When the company revealed on November 3, 2025 that the FDA no longer agreed the Phase I/II external-control data may be adequate to support a BLA, the stock fell $33.40 per share, or more than 49%, from the October 31 close of $67.69 to close at $34.29 on November 3.
Next Steps
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The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.
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The Court will then consider motion for class certification.
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The Court will later consider a Motion to Dismiss.
Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.
Frequently Asked Questions
What is the uniQure N.V. securities class action lawsuit about?
The lawsuit alleges that uniQure N.V. (NASDAQ: QURE) and certain executives made materially false and misleading statements about the company's lead drug candidate, AMT-130, a gene therapy for Huntington's disease. According to the complaint, defendants misrepresented that the FDA had approved the company's clinical trial design, including the use of an external historical dataset (ENROLL-HD) as a comparator for regulatory approval. The lawsuit claims these misrepresentations artificially inflated the stock price before the truth emerged.
What is the class period for the uniQure lawsuit?
The class period runs from September 24, 2025, through October 31, 2025, inclusive. During this time, the complaint alleges that investors purchased uniQure ordinary shares at artificially inflated prices based on misleading statements about AMT-130's regulatory pathway. Investors who acquired QURE shares during this period may be eligible to participate in the class action.
What specific misrepresentations does the complaint allege?
The complaint alleges defendants misrepresented and failed to disclose that:
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The design of uniQure's Pivotal Study, including comparison to the ENROLL-HD external dataset, was not fully approved by the FDA
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Defendants downplayed the likelihood that the company would need to delay its BLA timeline to conduct additional studies
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As a result, statements about the company's business and prospects allegedly lacked a reasonable basis
What happened to uniQure's stock price?
According to the complaint, when uniQure announced positive trial results on September 24, 2025, the stock surged nearly 250%, from $13.66 to $47.50 per share. The stock continued rising above $70.00 by October 29, 2025. However, when the company revealed on November 3, 2025, that the FDA "currently no longer agrees" the trial data could support a BLA submission, QURE shares plummeted over 49%, falling from $67.69 to $34.29 per share.
Who are the defendants named in the uniQure lawsuit?
The lawsuit names uniQure N.V. and four individual defendants: Matthew Kapusta (Chief Executive Officer), Christian Klemt (Chief Financial Officer), Walid Abi-Saab (Chief Medical Officer), and Sarah Tabrizi (lead investigator for the Pivotal Study and professor of clinical neurology). The complaint alleges these individuals had the power to control the company's public statements and knew or recklessly disregarded that their statements were false and misleading.
What legal claims are asserted in the complaint?
The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5. These provisions prohibit securities fraud, including making false statements or omitting material facts in connection with the purchase or sale of securities. The complaint seeks compensatory damages for investors who purchased uniQure shares during the class period.
What was the September 2025 stock offering mentioned in the lawsuit?
According to the complaint, shortly after announcing positive trial results, uniQure conducted a public offering of over 5.7 million ordinary shares and more than 500,000 pre-funded warrants, generating approximately $345 million in proceeds. The complaint alleges the prospectus stated proceeds would fund "commercialization readiness activities" and the "potential commercial launch of AMT-130," despite uncertainty about FDA approval.
What is the uniQure class action about?
The lawsuit alleges uniQure (NASDAQ: QURE) misled investors about FDA approval of its clinical trial design for AMT-130, a Huntington's disease treatment. According to the complaint, defendants misrepresented that the FDA agreed the ENROLL-HD external control approach could serve as primary evidence for a BLA, when the FDA later stated it no longer agreed that this approach may be adequate.
What is the class period?
The class period is September 24, 2025, through October 31, 2025. Investors who purchased uniQure ordinary shares during this time may be eligible to participate in the lawsuit.
How much did uniQure stock drop?
According to the complaint, QURE shares fell over 49% on November 3, 2025, dropping from $67.69 to $34.29, after the company revealed the FDA no longer agreed the trial data could support approval.
Who are the defendants?
The lawsuit names uniQure N.V. and executives Matthew Kapusta (CEO), Christian Klemt (CFO), Walid Abi-Saab (CMO), and Sarah Tabrizi (lead investigator). The complaint alleges they controlled and approved misleading statements.
What legal claims are involved?
The complaint asserts violations of Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5, seeking damages for investors who purchased shares during the class period.
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