uniQure N.V. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against uniQure N.V. (QURE)

If you purchased or acquired uniQure securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About uniQure

uniQure is a biotechnology company focused on developing gene therapies for patients with severe genetic diseases.

The company’s lead program, AMT-130, is designed as a potential treatment for Huntington’s disease, a rare and progressive neurodegenerative disorder.

Potential Concerns Under Investigation

Attorneys are reviewing whether uniQure and certain executives may have made false or misleading statements or failed to disclose material information regarding the Company’s lead therapy AMT-130 and its regulatory progress between June 2, 2025, and October 31, 2025.

On July 29, 2025, uniQure stated it had “achieved alignment with the FDA on the AMT-130 clinical development plan and CMC requirements to support a planned BLA submission in the first quarter of 2026,” adding that the alignment supported pursuit of the Accelerated Approval pathway. These statements may have led investors to believe that the FDA had agreed with the Company’s approach and that existing data would be sufficient for approval.

The Company reportedly reiterated this plan several times. In a September 24, 2025 update, uniQure again said it “plans to submit a BLA in the first quarter of 2026,” allegedly without cautioning investors about potential regulatory uncertainty or the need for additional data.

uniQure also stated that, “based on interactions with the FDA, it was agreed that data from the trials could be compared to a propensity score-matched external control dataset, which may serve as the primary basis for a BLA submission.” However, on November 3, 2025, uniQure disclosed that the FDA no longer viewed its Phase I/II data as adequate to support a BLA filing, contradicting earlier statements about alignment and approval prospects.

Following this announcement, the Company’s stock plunged nearly 50%, from $67.69 on October 31 to closing at 34.29 on November 3, 2025, nearly halving the stock's value.

Lawyers are investigating whether uniQure’s prior disclosures about its regulatory interactions and BLA timeline were misleading and whether investors were adequately warned about the risk of an adverse FDA determination.

Your Rights and Next Steps

This is an ongoing investigation and not a filed lawsuit. Investors who purchased or otherwise acquired uniQure securities between June 2025 and October 31, 2025, and suffered losses may have legal rights. If evidence shows that investors were misled, the case could lead to a class-action lawsuit to recover damages for affected shareholders.

Lawyers are available to help investors review their options and determine whether they qualify to participate. There is no cost or obligation to join the investigation, and participation is confidential.

You May Be Entitled to Compensation

Securities investigations are time-sensitive. Investors who purchased uniQure securities and suffered losses may be eligible to join any potential class action and seek compensation for their damages.

To protect your rights and participate in the investigation, complete the form below.