RADNOR, Pa.–(BUSINESS WIRE)–#classaction—Kessler Topaz Meltzer & Check, LLP informs investors that the firm has filed a securities fraud class action lawsuit against uniQure N.V. (NASDAQ: QURE) (“uniQure” or the “Company”) on behalf of investors who purchased or acquired uniQure ordinary shares between September 24, 2025, and October 31, 2025, inclusive (the “Class Period”). This action, captioned Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124, was filed in the United States District Court for the Southern District of New York.
Important Deadline Reminder: Investors who purchased or otherwise acquired uniQure ordinary shares during the Class Period may, no later than April 13, 2026, move the Court to serve as lead plaintiff for the class.
CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP (KTMC):
If you experienced losses in connection with uniQure, contact Kessler Topaz Meltzer & Check, LLP at:
You can also contact attorney Jonathan Naji, Esq. by calling (484) 270-1453 or by email at [email protected].
UNIQURE N.V. CLASS ACTION LAWSUIT COMPLAINT ALLEGATIONS
uniQure is a biotechnology company developing gene therapies for rare diseases, including Huntington’s disease (“HD”). uniQure is incorporated in The Netherlands with its principal executive offices in Amsterdam, The Netherlands.
The Company’s leading drug candidate is AMT-130, a novel gene therapy being developed to slow the progression of HD, a usually fatal, inherited genetic disorder that causes nerve cells in the brain to break down, leading to problems with movement and thinking, as well as psychiatric issues. There is no existing cure or approved means for slowing the progression of the disease. Some drugs can address certain HD symptoms, but do not halt its progression to a usually fatal outcome. AMT-130 is one of a very few drugs in testing intended to slow the progression of HD. In March 2022, uniQure completed patient enrollment for two, ongoing multi-center, dose-escalating Phase I/II clinical trials for AMT-130 called the Pivotal Phase I/II Study of AMT-130 in patients with HD (the “Pivotal Study”).
According to the Defendants, the U.S. Food and Drug Administration (“FDA”) previously agreed that uniQure’s Pivotal Study would not include any placebo comparator, but instead, the Pivotal Study results could be compared to an external historical data set, known as Enroll-HD or ENROLL-HD, and the analysis derived from such comparison potentially could serve as the basis for uniQure’s Biologics License Application (“BLA”) submission to the FDA for approval to use AMT-130 to treat patients with HD.
Indeed, Defendant Matthew Kapusta, the Company’s Chief Executive Officer, assured investors of the Company’s alignment with the FDA during calls with investors on June 2, 2025, and July 29, 2025.
The Class Period begins on September 24, 2025, when the Company announced topline results of the Pivotal Study. Notably, the Company emphasized that AMT-130 saw a “mean reduction from baseline in cerebrospinal neurofilament light protein” (“CSF NfL”)—which uniQure asserted was “a well-characterized, supportive biomarker of neurodegeneration.” Accordingly, uniQure explained that “[e]levation in CSF NfL has been shown to be strongly associated with greater clinical severity of [HD].” Thus, based on the totality of the results and as compared to data from ENROLL-HD, investors were led to believe that AMT-130 was effective in slowing the neurodegeneration in patients with HD and that uniQure would file for accelerated approval of a BLA for AMT-130 in the near-term. During the related investor conference held that same day, Defendant Kapusta touted the study results and asserted that “we believe these findings provide compelling and clinically meaningful evidence of AMT-130 disease modifying potential.”
Additionally, Defendant Walid Abi-Saab, the Company’s Chief Medical Officer, reminded investors that uniQure previously discussed the trial design with the FDA and that the FDA agreed that “cUHDRS could serve as an acceptable registrational, intermediate clinical endpoint for accelerated approval.” Moreover, he stated that “[t]he FDA also agreed that ENROLL-HD . . . may be acceptable as the external control dataset for the primary analysis, with each dose matched the corresponding controls based on their baseline characteristics.” Thus, investors were led to believe that there was a high likelihood that AMT-130 would receive accelerated approval from the FDA after the Company’s planned BLA submission in the first quarter of 2026. The market acted accordingly and, in response to Defendants’ statements, the price of the Company’s ordinary shares jumped from a close of $13.66 per share on September 23, 2025, to close at $47.50 per share on September 24, 2025, a nearly 250% increase. By October 29, 2025, uniQure ordinary shares were trading above $70.00 per share.
Capitalizing on the substantial increase in the value of uniQure ordinary shares, the Company publicly offered more than 5.7 million uniQure ordinary shares, and more than 500,000 pre-funded warrants to purchase ordinary shares, over the next several days after the release of the Pivotal Study results (the “September 2025 Offering”). Despite the fact that AMT-130’s future remained uncertain pending uniQure’s discussion of the Pivotal Study results with the FDA, in the prospectus supplement to the September 2025 Offering, uniQure explained that it was engaging in the September 2025 Offering in order to “fund our commercialization readiness activities” and “the potential commercial launch of AMT-130 and related commercialization activities.” Through the September 2025 Offering, uniQure generated approximately $345 million in proceeds (before expenses).
Investors learned the truth about the Company’s prospects and the BLA timeline for AMT-130 on November 3, 2025, when uniQure revealed that “the FDA currently no longer agrees that the data from the Phase I/II studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission.” Although the Company “plan[ned] to urgently interact with the FDA to find a path forward for the timely accelerated approval of AMT-130,” uniQure admitted that “the timing of the BLA submission for AMT-130 is now unclear.” On this news, the price of uniQure ordinary shares plummeted $33.40 per share, or more than 49%, from a close of $67.69 per share on October 31, 2025, to close at $34.29 per share on November 3, 2025.
The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the Company’s business and operations. Specifically, Defendants misrepresented 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 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.
THE LEAD PLAINTIFF PROCESS FOR UNIQURE INVESTORS:
uniQure investors may, no later than April 13, 2026, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check, LLP encourages uniQure investors to contact the firm directly for more information about the lawsuit.
ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP (KTMC):
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs’ Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. For more information about Kessler Topaz Meltzer & Check, LLP, please visit www.ktmc.com.
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Contacts
Jonathan Naji, Esq.
(484) 270-1453
280 King of Prussia Road
Radnor, PA 19087
[email protected]
