UniQure FDA Dispute and Lawsuit
Analysis based on 25 articles · First reported Apr 01, 2026 · Last updated Apr 13, 2026
The market is negatively impacted by the uncertainty surrounding UniQure's gene therapy candidate AMT-130 and the ongoing securities class action lawsuit. UniQure's stock price plummeted by over 49% following the United States — Food and Drug Administration's disclosure, indicating significant investor concern about the company's future prospects and regulatory compliance.
UniQure is facing a securities class action lawsuit filed by law firms Kahn Swick & Foti and S.D.N.Y. following public rebukes from the United States — Food and Drug Administration. The lawsuit alleges that UniQure misrepresented its interactions with the United States — Food and Drug Administration regarding its lead gene therapy candidate, AMT-130, and used a pivotal study design that the agency had not approved. The United States — Food and Drug Administration publicly criticized UniQure, calling AMT-130 a 'failed therapy' and accusing the company of 'distorted or manipulated comparison' in its clinical studies. This led to a significant drop of over 49% in UniQure's stock price on November 3, 2025, after the company disclosed that the United States — Food and Drug Administration no longer agreed with its data for the Biologics License Application submission, making the timing unclear. Investors who purchased UniQure shares between September 24, 2025, and October 31, 2025, have until April 13, 2026, to file lead plaintiff applications.
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