Class Actions Allege uniQure N.V. Misled Investors on Huntington’s Trial Design and FDA Backing

Allegations Over Pivotal Study Design Spur Multiple Class Actions

Multiple U.S. plaintiff firms announce class actions against uniQure N.V. on Feb. 13, 2026, alleging the Dutch gene‑therapy company misled investors about the regulatory status and design of its pivotal study for a Huntington’s disease therapy. Schall Law Firm, DJS Law Group and Rosen Law Firm say uniQure made materially false and misleading statements between Sept. 24, 2025 and Oct. 31, 2025 about the study’s comparability to the ENROLL‑HD external historical data set and about whether the study design had secured the full backing of the U.S. Food and Drug Administration. The complaints assert violations of Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b‑5.

Plaintiffs contend uniQure understates the likelihood that it would need to delay its Biologics License Application (BLA) to gather supplemental data, and that public statements gave investors an unwarranted impression that the pivotal study would satisfy FDA requirements. The filings say the ENROLL‑HD comparison and other disclosures lack a reasonable basis and thus misrepresent the company’s regulatory prospects. Firms allege investors sustained losses once the alleged deficiencies became known and seek recovery on behalf of purchasers during the specified class period.

The litigation framework is already taking shape: the notices identify a lead‑plaintiff deadline of April 13, 2026 and invite affected shareholders worldwide to preserve records and consider joining the cases. None of the proposed classes is certified, and firms note that participation and any eventual recovery depend on court rulings, proof of damages and procedural steps that plaintiffs must take to protect claims.

Law Firms’ Outreach and Litigation Mechanics

Each firm is soliciting potential class members and stresses typical contingency fee arrangements and no out‑of‑pocket costs for initial consultations. The notices emphasize the role of a lead plaintiff, potential timelines, and the need for claimants to assemble trading confirmations and related documents to support any action.

Regulatory and Industry Context

uniQure, which develops gene therapies including a lead program for Huntington’s disease, faces heightened scrutiny of its public communications and regulatory pathway as these suits proceed. The lawsuits center on whether the company adequately disclosed regulatory risks tied to trial design and external control comparisons, a matter that could affect future interactions with regulators and investor communications in the gene‑therapy sector.