uniQure Faces Class Action Over Alleged Misleading Statements on Drug Approval

Reuters
02/14
uniQure Faces Class Action Over Alleged Misleading Statements on Drug Approval

A class action lawsuit has been filed against uniQure NV on behalf of investors who purchased the company’s ordinary shares between September 24, 2025, and October 31, 2025. The litigation alleges that uniQure misled investors regarding the likelihood of FDA approval for its leading drug candidate, AMT-130. According to the complaint, the company failed to disclose that the design of its pivotal study was not fully approved by the FDA and that additional studies might be required, potentially delaying its biologics license application. On November 3, 2025, uniQure announced the FDA no longer agreed that the data from its Phase I/II studies would be adequate for primary evidence in a BLA submission, leading to a sharp drop in the company’s stock price. Investors wishing to serve as lead plaintiff must submit court papers by April 13, 2026. All representation is on a contingency fee basis, and shareholders pay no fees or expenses.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. uniQure NV published the original content used to generate this news brief via PR Newswire (Ref. ID: 202602131736PR_NEWS_USPR_____LA88162) on February 13, 2026, and is solely responsible for the information contained therein.

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