The Schall Law Firm has initiated a securities fraud class action lawsuit against uniQure N.V. (NASDAQ: QURE), targeting investors who purchased company securities during a specific four-month window from September 24, 2025, through October 31, 2025. The litigation centers on allegations that the biopharmaceutical company made materially false and misleading statements regarding FDA approval processes for its Pivotal Study and provided inaccurate representations about the timeline for its Biologics License Application (BLA) submission.
According to the complaint, these alleged misstatements resulted in significant investor losses as the market price of QURE shares declined following the disclosure of accurate information. The case represents a common occurrence in the biotech sector, where regulatory announcements and clinical trial progress significantly impact investor valuations. Investors who held company securities during the identified period and experienced losses may be eligible to participate in the class action.
The lawsuit seeks to recover damages on behalf of affected shareholders. Class actions of this nature typically require demonstration of materiality—that the alleged misstatements were significant enough to influence investment decisions—and causation linking the misrepresentations to subsequent stock price declines. uniQure, a gene therapy company, has not yet publicly responded to the litigation allegations.