uniQure Faces Securities Fraud Lawsuit
A class action lawsuit has been filed against gene therapy company uniQure N.V. for alleged violations of the Securities Exchange Act. The Schall Law Firm is reminding investors of the opportunity to act as lead plaintiff in the case.
- The lawsuit centers on AMT-130, uniQure's investigational AAV gene therapy for Huntington's disease, which previously received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA. - Allegations state that uniQure failed to disclose that the FDA had not fully approved the design of its pivotal study for AMT-130, specifically its plan to use an external historical data set (ENROLL-HD) as a comparator for its Biologics License Application (BLA). - The class period for the lawsuit began on September 24, 2025, immediately after uniQure announced positive topline data suggesting AMT-130 could significantly slow Huntington's disease progression, causing the company's stock to surge nearly 250%. - The core issue arose on November 3, 2025, when uniQure revealed the FDA no longer agreed that the existing Phase I/II data would be adequate to support a BLA submission, making the approval timeline "unclear." - Following the November disclosure about the FDA's stance, uniQure's stock price plummeted by more than 49%, falling from a close of $67.69 on October 31, 2025, to $34.29 on November 3, 2025. - Investors seeking to be appointed as lead plaintiff in the case, captioned *Scocco v. uniQure N.V., et al.*, have a deadline of April 13, 2026. - This regulatory setback for the Huntington's program follows uniQure's success with Hemgenix (etranacogene dezaparvovec), the first FDA-approved gene therapy for Hemophilia B, which is marketed by CSL Behring and has a list price of $3.5 million.
