Robbins LLP Brings Attention to Class Action Against uniQure N.V. Over Misleading FDA Approval Claims

Robbins LLP Raises Alarm on uniQure N.V. Class Action

In a recent announcement, Robbins LLP has alerted stockholders about a class action brought against uniQure N.V. (NASDAQ: QURE). This lawsuit concerns all investors who acquired ordinary shares of the company between September 24, 2025, and October 31, 2025. As a biotechnology firm, uniQure focuses on developing innovative gene therapies aimed at treating rare diseases.

The Nature of the Allegations

The lawsuit's premise revolves around allegations that uniQure misled investors regarding the likelihood of receiving FDA approval for its leading drug candidate, AMT-130. Specifically, the complaint notes that the defendants did not fully disclose two critical issues:
1. FDA Approval Status: The pivotal study design used by uniQure, which compared its results to external historical data, lacked complete FDA approval.
2. Delays in Approval Timeline: The company supposedly downplayed the risk of needing to postpone its Biologics License Application (BLA) timeline while conducting further studies required for the BLA submission.

On November 3, 2025, uniQure revealed that feedback from the FDA indicated serious concerns about the adequacy of their data in supporting the BLA submission. Despite previously claiming highly successful results from its pivotal study, the FDA no longer considered the data sufficient for approval.

This revelation caused a significant drop in share prices, with uniQure's stock plummeting by $33.40, or more than 49%, from $67.69 on October 31, 2025, to just $34.29 on November 3, 2025.

What Does This Mean for Investors?

Investors who purchased shares during the specified timeframe may be eligible to join the class action. Those interested in becoming lead plaintiffs must submit the necessary documentation to the court by April 13, 2026. Serving as a lead plaintiff involves representing group interests and guiding the litigation process, although it's not a requirement for recovery.

If individuals choose not to take direct action, they still retain their status as a passive class member, with no obligation to participate actively in the lawsuit. This arrangement allows investors to remain informed and possibly benefit from any resolutions without further engagement.

All representation in this case will be based on a contingency fee structure, meaning shareholders won't incur upfront costs or expenses.

About Robbins LLP

Founded in 2002, Robbins LLP is a recognized advocate for shareholder rights, working diligently to help investors recover losses, enhance corporate governance, and hold executives responsible for their actions. Their commitment to ensuring accountability in corporate practices has made them pioneers in the legal landscape concerning investor advocacy.

For those who want to stay updated on the class action against uniQure N.V. or to receive alerts should any misconduct be identified among corporate executives, signing up for Stock Watch could be beneficial.

In summary, Robbins LLP is shining a light on potential investor misconduct and urges affected shareholders to explore their options in the class action against uniQure N.V. The legal landscape for investors can be complex, but with the right resources and guidance, affected shareholders can take action to protect their interests.