Hagens Berman is updating its investigation into uniQure N.V. after federal health officials publicly rebuked the company.

National shareholder rights law firm Hagens Berman is updating its investigation into uniQure N.V. (NASDAQ: QURE) following an unprecedented public rebuke of the company by federal health officials. This investigation follows the filing of a securities class action lawsuit seeking to represent investors who purchased or otherwise acquired uniQure ordinary shares between September 24, 2025, and October 31, 2025 (the "Class Period").

On March 5, 2026, The Wall Street Journal published "Federal Health Officials Attack Rare-Disease Drug, Say Company Lied," reporting on unusual public criticism by officials at the Food and Drug Administration and Department of Health and Human Resources directed at uniQure N.V. (NASDAQ: QURE).

According to the report, "[a] senior FDA official said in a call with reporters Thursday that the data from the testing of Uniqure's gene therapy were flawed and signaled the drug candidate didn't meet the bar for agency approval." The therapy at issue is uniQure's lead gene therapy candidate, AMT-130, which is being developed to slow the progression of Huntington's disease.

Worse, the WSJ reported "[t]he official also said a Uniqure executive had mischaracterized the FDA's request for how to compare the therapy to a placebo[]" and "[a]n HHS official said the company had 'lied' and put out misleading statements."

The next day, STAT reported "[w]hat started months ago as a scientific disagreement between the FDA and UniQure over how best to study a gene therapy for Huntington's disease metastasized on Thursday into a diatribe by the senior FDA official, who accused UniQure of pushing 'distorted' and 'manipulated' clinical data for a 'failed' therapy."

The reports follow a series of devastating reports, beginning November 3, 2025, that have driven the price of uniQure shares down nearly 84% by the time of the WSJ publication, and the filing of a securities class action lawsuit.

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