Expired
Lead Plaintiff Deadline
Apr 13, 2026
Please Upload related files below
Fill in below.
Tell us the stocks you own using SnapTrade, and we will keep you informed about class action litigation related to your stocks. We monitor critical case developments that may affect the price of your shares and your possible monetary recovery. SnapTrade only shares the tickers you own and your transaction history, not your account numbers. Using SnapTrade and participating in our monitoring service is free and does not create any attorney-client relationship or obligation on your part.
Don’t miss out on possible monetary recovery - link your brokerage account with SnapTrade.
The filed complaint alleges that uniQure N.V made materially false and/or misleading statements and/or failed to disclose that: (1) the design of uniQure’s Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; (2) defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its Biologics License Application (“BLA”) timeline to perform additional studies to supplement its BLA submission; and (3) as a result, defendants’ statements about the Company’s business, operations, and prospects lacked a reasonable basis.
In order to be eligible to join the QURE class action lawsuit, you must have incurred a loss on shares of uniQure purchased during the class period listed above.
If you suffered a loss in uniQure during the relevant time frame or pursuant to the relevant offering(s), you have until April 13, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
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.
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 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.
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.
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 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.
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.
The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.
The Court will then consider motion for class certification.
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.
TOP