#FDA #Hagens Berman #uniQure

Hagens Berman Updates on uniQure Investigation

In the wake of shocking allegations from the Food and Drug Administration (FDA), Hagens Berman, a prominent shareholder rights law firm, is ramping up its investigation into uniQure N.V. (NASDAQ: QURE). The FDA's claims regarding uniQure's gene therapy candidate, AMT-130, have sparked significant concern among investors and the public alike.

Investigative Context

Recent reports from various respected media outlets have highlighted a troubling interaction between uniQure's representatives and FDA officials. During a press call held on March 5, 2026, an FDA spokesperson characterized AMT-130 as a “failed therapy.” This official asserted that uniQure was using skewed comparisons, showcasing what they deemed as “manipulated” data instead of adhering to proper clinical study protocols.

Hagens Berman is currently advising investors who acquired uniQure shares within the class period from September 24, 2025, to October 31, 2025—an essential timeframe for potential legal recourse. The firm has reminded affected investors that the deadline to appoint a Lead Plaintiff in the pending class action lawsuit is April 13, 2026.

Distorted Practices Alleged

The crux of the controversy revolves around uniQure's approach to clinical testing, specifically its use of sham surgeries. An FDA official criticized uniQure for misrepresenting the nature of these procedures, clarifying that the agency had not requested extensive surgical interventions. Instead, the official emphasized that any surgical requirement would entail only minor scalp nicks under minimal anesthesia.

Furthermore, uniQure's CEO had previously described these demands as a significant deviation from earlier guidance, an assertion the FDA has refuted. The FDA firmly stated that they never consented to what uniQure considered a