uniQure N.V. Website

uniQure N.V.

NasdaqGS-QURE

Company Overview

uniQure N.V., a gene therapy company, engages in the development of treatments for patients suffering from genetic and other devastating diseases. Its lead program is Etranacogene dezaparvovec (AMT-061), which is in Phase III HOPE-B pivotal trial for the treatment of hemophilia B. The company also engages in developing AMT-130, a gene therapy that is in Phase I/II clinical study for the treatment of Huntington's disease; AMT-060, which is in Phase I/II clinical trial for the treatment of hemophilia B; AMT-210, a product candidate for the treatment of Parkinson's disease; AMT-260 for temporal lobe epilepsy; AMT-240, a preclinical product candidate for the treatment of autosomal dominant Alzheimer's disease; and AMT-161 for the treatment of amyotrophic lateral sclerosis. uniQure N.V. was founded in 1998 and is headquartered in Amsterdam, the Netherlands.

  • Name

    uniQure N.V.

  • CEO

    Matthew Craig Kapusta

  • Website

    www.uniqure.com

  • Sector

    Biotechnology

  • Year Founded

    1998

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What's happening

Nov 13, 2025 - Dec 13, 2025

uniQure NV Faces Severe Setback Amid Regulatory Challenges

  • The FDA deemed data from Phase I/II studies insufficient for a Biologics License Application, triggering a sharp market reaction.
  • Analysts have lowered price targets significantly due to growing skepticism about the company's future performance.
  • Investor anxiety is heightened by discussions of potential securities fraud investigations linked to misleading statements.

Over the past month, uniQure NV (QURE) experienced a significant decline of 35.2%. This downturn sharply contrasts with the S&P 500's minor drop of only 0.2%. The primary catalyst for this bearish sentiment was regulatory setbacks concerning its investigational gene therapy AMT-130 for Huntington's disease. Following an announcement on November 3 that the FDA found Phase I/II study data inadequate to support a Biologics License Application (BLA), shares plummeted over 50%.

The negative impact continued into December as analysts revised their price targets downward in light of ongoing unfavorable news regarding QURE. Stifel maintained a Buy rating but reduced its target significantly to $40, while Mizuho adjusted its target downwards to $33 amid increasing concerns about the company’s ability to overcome current challenges effectively.

Despite some positive narratives surrounding advancements in Huntington's disease research and recognition of key scientists involved in gene therapies, these developments failed to counteract prevailing bearish trends affecting QURE’s stock price. Positive news related to HEMGENIX® was overshadowed by persistent discussions regarding AMT-130’s regulatory pathway and investor frustrations with leadership decisions at uniQure.

Investor anxiety further intensified due to social media discussions highlighting potential securities fraud investigations linked to misleading statements made prior to recent declines. As stakeholders awaited clarity on upcoming meetings with the FDA scheduled for early next year, caution dominated market sentiment during this one-month period characterized by substantial volatility and uncertainty for QURE. Notably, uniQure NV underperformed not just against broader market indices but also within its sector; specifically, it underperformed the Health Care (XLV) sector by -36.0%.

NasdaqGS:QURE