Why is uniQure facing a securities class action lawsuit?

Investors allege uniQure misled the market about FDA approval of its pivotal study design and downplayed the risk that additional studies would be required, delaying the company’s biologics license application timeline.

What is the pivotal study issue alleged against uniQure?

The lawsuit claims uniQure compared trial results to an external historical dataset without full FDA approval of that study design, calling into question the regulatory strength of its reported results.

Why does FDA approval of a study design matter to investors?

FDA agreement on trial design is critical for a successful BLA. Without it, regulators may require additional studies, causing delays, higher costs, and reduced approval odds.

What are investors alleging about uniQure’s BLA timeline?

Investors allege uniQure understated the likelihood it would need to delay its BLA submission to conduct further studies, making public statements about timing and prospects misleading.

What is the deadline to seek lead plaintiff status in the uniQure lawsuit?

Investors seeking to serve as lead plaintiff in the federal securities class action against uniQure must file a motion by April 13, 2026, to preserve their right to represent the class.

uniQure N.V. - Faruqi & Faruqi LLP

uniQure N.V.

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Case Details

Ticker QURE

Class Period 09/24/2025 - 10/31/2025

Lead Plaintiff Deadline 04/13/2026

Days Left to Seek Plaintiff

If you are a uniQure investor who suffered a loss and would like to learn more, you can provide your information below:

If you purchased or acquired securities in uniQure between September 24, 2025 and October 31, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).

Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against uniQure N.V. (“uniQure” or the “Company”) (NASDAQ: QURE) and reminds investors of the April 13, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing 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; (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; and (3) as a result, Defendants’ statements about the Company’s business, operations, and prospects lacked a reasonable basis.

Lead Plaintiff Deadline: April 13, 2026

Call Partner Josh Wilson at 877-247-4292 or 212-983-9330 (Ext. 1310)
Or submit your information below to learn about your rights.

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