Lawsuits Accuse uniQure N.V. of Misleading Statements on Huntington’s Trial and FDA Path

Legal Pressure Mounts Over uniQure’s Huntington’s Disease Program

Class actions allege misleading regulatory and trial representations

Several plaintiff law firms are filing competing class actions against gene‑therapy developer uniQure N.V., alleging the company makes false and misleading statements about the regulatory status and pivotal trial data for its Huntington’s disease candidate. The Schall Law Firm, DJS Law Group and Rosen Law Firm notify investors they have prepared complaints asserting violations of Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b‑5 tied to public statements about the design and regulatory acceptance of uniQure’s Pivotal Study and its comparison to the ENROLL‑HD external historical data set. The suits focus on assertions that those public representations overstated the study’s alignment with FDA expectations.

The complaints claim uniQure failed to obtain full FDA approval of the Pivotal Study design and understated the likelihood that its Biologics License Application (BLA) timeline will require supplementation with additional data or delay. Plaintiffs say the company’s characterization of the Pivotal Study and the ENROLL‑HD comparison lacks a reasonable basis and that investors suffer losses when the purported deficiencies surface. Each filing frames the alleged misstatements as material to assessments of uniQure’s regulatory path and commercial prospects for its leading Huntington’s disease program.

Procedural notices accompanying the filings set a class period from Sept. 24, 2025 through Oct. 31, 2025 and invite eligible purchasers to seek appointment as lead plaintiff or to join the litigation. Firms note a deadline of April 13, 2026 to move for lead‑plaintiff status and stress that class certification has not occurred; investors who do not act may remain absent class members and are not yet represented by counsel. Rosen and other firms describe contingency‑fee arrangements and offer free initial consultations, while urging potential claimants to preserve trading records and related documents.

Firms publicize global outreach and investor services

The plaintiff firms distribute their notices via PRNewswire and direct shareholders worldwide to contact them for information on potential recoveries, damages calculations and filing procedures, while cautioning that the communications may constitute attorney advertising in some jurisdictions.

Regulatory and company response remain unclear

The litigation intensifies scrutiny of uniQure’s development and regulatory processes for its Huntington’s disease therapy. The press notices do not include a response from uniQure, and it is not yet known how regulators or the company will address the allegations.