Securities Suit Against uniQure N.V. Over AMT‑130 Accelerated‑Approval Regulatory Dispute

Court challenge focuses on uniQure’s AMT‑130 regulatory pathway

A securities class action is proceeding against uniQure N.V., centering on the company’s representations about the regulatory prospects for its lead gene‑therapy candidate, AMT‑130. The complaint, brought by plaintiffs represented by law firm Kahn Swick & Foti (KSF), alleges that uniQure and certain executives failed to disclose material information during a defined Class Period from Sept. 24, 2025 through Oct. 31, 2025. The suit contends investors were led to believe a high likelihood existed that AMT‑130 would be eligible for accelerated approval following a planned Biologics License Application (BLA) submission in the first quarter of 2026.

The complaint highlights a Nov. 3, 2025 disclosure in which uniQure announced that the U.S. Food and Drug Administration “no longer agrees” that Phase I/II data compared to an external control — as assessed under prespecified protocols and statistical analysis plans — supports the accelerated approval pathway. Plaintiffs say that information is material and that its absence during the Class Period forms the basis for alleged violations of federal securities laws. The action is pending in the United States District Court for the Southern District of New York.

The litigation raises questions about how companies communicate regulatory expectations for pioneering gene therapies and the consequences when regulatory assessments change. Plaintiffs argue the FDA’s revised position undermines the prior public portrayal of AMT‑130’s regulatory trajectory, creating a duty to disclose the agency’s apparent disagreement. The case is likely to probe internal company communications, timing of regulatory interactions, and the standard for what constitutes adequate public disclosure concerning pre‑approval data and external control comparisons.

Lead plaintiff deadline and participation details

KSF is inviting investors who purchased or otherwise acquired uniQure shares during the Class Period to contact the firm and warns that anyone wishing to seek designation as lead plaintiff must file a motion by April 13, 2026. The firm provides a toll‑free number (1‑877‑515‑1850), an email address ([email protected]) and a case webpage for no‑obligation contact.

Firm background and potential remedies

KSF emphasizes that participation may enable affected investors to seek recovery through the class action process and notes its prior experience in shareholder recoveries. The firm stresses contacts are free and confidential and that an appointed lead plaintiff can direct and control the litigation.