uniQure AMT-130 FDA Data Insufficient
Analysis based on 8 articles · First reported Nov 14, 2025 · Last updated Jan 12, 2026
The market was significantly impacted by the over 50% drop in UniQure's stock price, reflecting investor concern over the future of its AMT-130 gene therapy. This event highlights the regulatory risks in the biotechnology sector, potentially leading to increased scrutiny of other companies with therapies in the BLA submission phase.
UniQure N.V. experienced a dramatic stock price decline of over 50% on November 3, 2025, after the United States — Food and Drug Administration informed the company that data for its investigational gene therapy, AMT-130, was insufficient to support a Biologics License Application submission. This regulatory setback has cast uncertainty on the timing of the BLA submission for AMT-130, a gene therapy for Huntington's disease. In response to this significant market event, the law firm Kessler Topaz Meltzer & Check has initiated an investigation into potential violations of federal securities laws on behalf of UniQure investors.
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