Robbins LLP is Investigating Allegations that uniQure (QURE) Misled Investors Regarding the Likelihood of FDA Approval of its Leading Drug Candidate, AMT-130

Robbins LLP informs stockholders that a class action was filed on behalf of all investors who purchased or otherwise acquired uniQure N.V. (NASDAQ: QURE) ordinary shares between September 24, 2025 and October 31, 2025. uniQure is a biotechnology company developing gene therapies for rare diseases.

The Allegations:

According to the complaint, defendants failed to disclose that: (1) the design of uniQure’s Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; and (2) Defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its BLA timeline to perform additional studies to supplement its BLA submission.

Plaintiff alleges that on November 3, 2025, uniQure announced that it had received feedback from the FDA about AMT-130’s path to BLA approval. uniQure revealed that the FDA “currently no longer agrees that the data from the Phase I/II studies of AMT-130 in comparison to [the ENROLL-HD] 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.” On this news, the price of uniQure ordinary 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.

What Now: You may be eligible to participate in the class action against uniQure N.V. Shareholders who wish to serve as lead plaintiff for the class must submit their papers to the court by April 7, 2026. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.