uniQure Faces Securities Class Action Over FDA Approval Delay for AMT-130

uniQure N.V. is facing a securities fraud class action lawsuit after the company disclosed that the FDA no longer agreed its drug candidate AMT-130 data was adequate for a Biologics License Application submission, leading to a 49% stock decline. The lawsuit alleges uniQure and certain of its executives failed to disclose material information during the class period from September 24, 2025 to October 31, 2025, violating federal securities laws.

During the class period, the company represented to investors that there was a high likelihood that its leading drug candidate, AMT-130, would receive accelerated approval from the U.S. Food and Drug Administration after the company's planned Biologics License Application submission in the first quarter of 2026. On November 3, 2025, uniQure disclosed the FDA no longer agreed the existing data was adequate to support a BLA submission.

On November 3, 2025, uniQure's stock price plummeted by $33.40, over 49%, from $67.69 on October 31 to $34.29, severely impacting investor confidence. The case is Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124.

Investors have until April 13, 2026 to file lead plaintiff applications in the securities class action lawsuit against uniQure. Those wishing to serve as lead plaintiffs must petition the court by the deadline to ensure compensation for their economic losses.

AMT-130 is uniQure's product candidate for patients with Huntington's disease. The lawsuit alleges that the company misled investors regarding the approval prospects of their drug candidate during the class period, potentially leading to significant liability.