Shares Collapse Over 49% on FDA Setback
UniQure N.V.'s stock (NASDAQ: QURE) collapsed on November 3, 2025, after the company revealed a critical disagreement with the U.S. Food and Drug Administration. Shares plummeted by $33.40, a loss of more than 49%, to close at $34.29 from a previous close of $67.69 on October 31. The sell-off was triggered by uniQure's announcement that the FDA no longer agreed that data from its Phase I/II studies of the gene therapy AMT-130, compared against an external control group, would be adequate to support a Biologics License Application (BLA) submission. This disclosure shattered investor expectations for an accelerated approval pathway for the company's leading drug candidate for Huntington's disease, leaving the BLA submission timeline "unclear."
Lawsuit Alleges Misleading Statements on AMT-130 Trial
A securities fraud class-action lawsuit now accuses uniQure of violating federal securities laws by misleading investors about its clinical progress. The suit covers investors who acquired shares between September 24, 2025, and October 31, 2025. It alleges that during this period, uniQure failed to disclose material adverse facts, including that the FDA had not fully approved the design of its pivotal study for AMT-130. The complaint claims the company misrepresented its dialogue with the regulator and downplayed the significant risk that it would need to conduct additional studies, thereby delaying its BLA submission. These alleged omissions and misstatements, according to the lawsuit, lacked a reasonable basis and artificially inflated the company's stock price before the eventual collapse.
Investors Face April 13 Lead Plaintiff Deadline
The lawsuit, filed in the United States District Court for the Southern District of New York, establishes a clear timeline for shareholder action. Investors who purchased uniQure shares during the defined class period may seek to be appointed as the lead plaintiff, a representative party that directs the litigation on behalf of all class members. The deadline for filing this motion with the court is April 13, 2026. This legal action creates significant financial and reputational risk for uniQure, potentially leading to substantial damages and diverting management's focus from its core drug development operations.
