Plaintiff Firms Step Up uniQure Solicitation After FDA Rebuke, With April 13 Lead-Plaintiff Deadline

Overview

• - Multiple shareholder firms, including Hagens Berman, DJS Law Group, the Schall Law Firm, Faruqi & Faruqi, and ClaimsFiler/KSF, urged investors to seek lead-plaintiff status by April 13, 2026.
• - Notices reference early March reports that an FDA official labeled AMT-130 a "failed therapy" and accused uniQure of using a distorted comparison instead of a proper study.
• - The official disputed uniQure’s characterization of a sham-surgery requirement, saying the agency sought only one to three small scalp nicks under minimal anesthesia.
• - The same official said the FDA never agreed to accept ENROLL-HD natural history data as a primary comparator and questioned eligibility for streamlined rare-disease pathways.
• - The pending SDNY class action, Scocco v. uniQure, cites the company’s Nov. 3, 2025 disclosure that upended its BLA timeline and preceded a share drop of more than 49%.