uniQure Faces Securities Fraud Lawsuit

The lawsuit centers on uniQure's lead gene therapy candidate, AMT-130, which is being developed for Huntington's disease, a fatal inherited neurodegenerative disorder with no cure. The complaint alleges the company misrepresented the high likelihood of the drug receiving accelerated approval from the U.S. Food and Drug Administration (FDA) based on its existing clinical data. On November 3, 2025, uniQure disclosed a significant setback in its communications with the FDA. The company announced the agency no longer agreed that data from the Phase I/II studies of AMT-130 would be adequate to support a Biologics License Application (BLA) for accelerated approval, rendering the submission timeline "unclear". The market reaction to the FDA news was severe and immediate. On the day of the announcement, uniQure's ordinary shares plummeted by more than 49%, dropping from a closing price of $67.69 per share on October 31, 2025, to $34.29. This single-day collapse erased $33.40 per share in value. Following a Type A meeting with uniQure on January 30, 2026, the FDA "strongly recommended" that the company conduct a new, more rigorous clinical trial. This would involve a prospective, randomized, double-blind, sham surgery-controlled study to provide primary evidence of the drug's effectiveness. The class action lawsuit, captioned *Scocco v. uniQure N.V., et al.*, was filed in the U.S. District Court for the Southern District of New York. Law firms Kessler Topaz Meltzer & Check, LLP, and Kahn Swick & Foti, LLC, are representing investors. The class period began on September 24, 2025, a day after uniQure's stock price soared by nearly 250%. The massive stock jump was fueled by the company's announcement of positive topline data from the pivotal Phase I/II study of AMT-130.