Archived Investigations
uniQure N.V. (NasdaqGS: QURE)
uniQure and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
During the Class Period, the Company represented to investors that there was a high likelihood that its leading drug candidate, AMT-130, would receive accelerated approval from the U.S. Food and Drug Administration (“FDA”) after the Company’s planned Biologics License Application (“BLA”) submission in the first quarter of 2026. However, on November 3, 2025, the Company disclosed that “the FDA currently no longer agrees that the data from the Phase I/II studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission” and as a result, “the timing of the BLA submission for AMT-130 is now unclear.”
On this news, the price of uniQure’s shares plummeted $33.40 per share, or more than 49%, from a close of $67.69 per share on October 31, 2025, to close at $34.29 per share on November 3, 2025.
The case is Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124.