Kirby McInerney LLP has initiated a securities fraud class action lawsuit against uniQure N.V., targeting investors who purchased company securities during a specific period from September 24, 2025 through October 31, 2025. The litigation centers on allegations that the biopharmaceutical company failed to disclose material information regarding FDA feedback on its Pivotal Study design and downplayed potential delays to its Biologics License Application submission timeline.
The legal action follows uniQure's November 3, 2025 announcement that the FDA no longer concurs that Phase I/II study data may constitute sufficient evidence for BLA submission. This disclosure prompted a significant market reaction, with uniQure's stock price declining from $67.69 to $34.29, representing a loss of 49.33% in shareholder value. The company's failure to communicate these regulatory concerns prior to the official announcement forms the basis of the plaintiffs' claims.
Investors who acquired uniQure securities during the identified window are encouraged to contact Kirby McInerney LLP, with an April 13, 2026 deadline noted for participation in the class action. The lawsuit represents efforts by shareholders to recover losses stemming from what is characterized as inadequate disclosure of regulatory obstacles affecting the company's drug approval pathway.