uniQure Faces FDA Rebuke Over Manipulated Drug Data

FDA Accuses uniQure of Using 'Manipulated' Drug Data

UniQure N.V. (NASDAQ: QURE) is facing a crisis of confidence after federal health officials, reportedly the U.S. Food and Drug Administration (FDA), publicly accused the company of pushing "distorted" and "manipulated" data for its Huntington's Disease drug, AMT-130. The rebuke, disclosed on March 17, 2026, prompted the national shareholder rights law firm Hagens Berman to immediately update its investigation into the company. This rare public condemnation from a regulator casts serious doubt on the integrity of uniQure's clinical trial results and the viability of its most promising asset.

Class Action Alleges Misleading Statements Since September 2025

The FDA's accusation amplifies an existing legal battle against uniQure. A securities fraud class action lawsuit alleges the company misled the market between September 24, 2025, and October 31, 2025. The core of the lawsuit claims uniQure failed to disclose that the design of its pivotal study for AMT-130 was not fully approved by the FDA. It also alleges executives downplayed the likelihood of delays to its Biologics License Application (BLA), thereby making public statements about its business prospects that lacked a reasonable basis.

Multiple law firms are now reminding investors of the April 13, 2026 deadline to file for lead plaintiff status in the lawsuit. The legal proceedings seek to recover damages for shareholders who purchased QURE shares during the specified class period. The combination of regulatory censure and shareholder litigation jeopardizes the future of AMT-130 and exposes uniQure to significant financial penalties and reputational damage.