Law Firms Urge uniQure Investors to Seek Lead Role as FDA Rebuke Bolsters Lawsuit

Overview

• Rosen Law and Hagens Berman are recruiting shareholders for a pending securities class action and reminding them of the April 13, 2026 lead‑plaintiff deadline.
• The firms say the suit, filed in the Southern District of New York, covers people who bought uniQure shares from September 24 to October 31, 2025.
• Media reports quoted an FDA official who called uniQure’s AMT‑130 a “failed therapy” and said the company used a “distorted or manipulated” comparison instead of a proper clinical study.
• The official also rejected uniQure’s account of sham‑surgery demands and said the agency never agreed to accept the ENROLL‑HD registry as the main control group.
• Plaintiffs allege the company misled investors about FDA agreement on the study design and the risk of extra studies that could delay a license application, which they say came into focus as shares fell 49% on November 3, 2025.