uniQure N.V. experienced a significant market decline after the U.S. Food and Drug Administration determined that clinical data for the company's gene therapy candidate AMT-130 did not meet the threshold for accelerated approval. The rejection triggered a sharp sell-off on November 3, 2025, with shares declining from $67.69 to $34.29, representing a 49% loss in shareholder value.
The regulatory setback has prompted securities litigation against the biopharmaceutical company. A class action lawsuit has been filed on behalf of investors who purchased uniQure shares between September 24 and October 31, 2025, the period preceding the FDA's decision. The case alleges potential securities fraud related to the company's public statements regarding the drug candidate's regulatory pathway.
Investors who meet the eligibility criteria and wish to participate in the litigation have until April 13, 2026, to submit lead plaintiff applications. Legal counsel representing the class action group is accepting inquiries from affected shareholders regarding their potential claims.