uniQure (QURE) Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of uniQure N.V. ("uniQure N.V." or the "Company") (QURE). Impacted investors are advised to contact the firm now.

The law firm is investigating whether uniQure and certain of its officers or directors may have made false or misleading statements or failed to disclose material information regarding the regulatory prospects of the Company’s lead gene therapy program, AMT-130, for Huntington’s disease between June 2025 and October 31, 2025.

On July 29, 2025, uniQure stated that 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 this alignment supported pursuit of the Accelerated Approval pathway. These assurances appeared to suggest that the FDA agreed with the Company’s approach and that existing clinical data would be sufficient for approval. In a September 24, 2025 update, the Company stated it “plans to submit a BLA in the first quarter of 2026,” allegedly without referencing any material regulatory risk or 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, the Company disclosed that the FDA no longer viewed the Phase I/II data for AMT-130 as adequate to support a BLA filing, potentially contradicting its earlier representations of alignment and approval readiness.

Following this disclosure, uniQure’s stock declined nearly 50%, falling from $67.69 on October 31 to $34.29 on November 3, 2025, causing significant losses for investors.

If you purchased or otherwise acquired uniQure (QURE) securities between June 2025 and October 31, 2025, you may be eligible to seek compensation for your losses. Contact Shamis & Gentile, P.A. today to discuss your options.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

Attorney advertising. Prior results do not guarantee similar outcomes.