#USA #Kessler Topaz #Radnor #uniQure #FDA Notice

Investigation of uniQure N.V. by Kessler Topaz Meltzer & Check, LLP

In a significant development for investors in uniQure N.V. (NASDAQ: QURE), Kessler Topaz Meltzer & Check, LLP, a prominent law firm, is launching an investigation into possible violations of federal securities laws. The investigation was prompted by a dramatic decline in uniQure's stock price, which was triggered by the company's announcement regarding its investigational gene therapy, AMT-130, intended for the treatment of Huntington's disease.

On November 3, 2025, uniQure disclosed that the U.S. Food and Drug Administration (FDA) deemed the data from their Phase I/II trials insufficient to support a Biologics License Application (BLA). This notification caused substantial alarm among investors as the company had previously expressed optimism regarding the viability of AMT-130. The FDA's directive raised serious questions about the drug's potential approval and the overall future of uniQure.

Impact on Stock Values

As a direct consequence of this FDA notification, uniQure's stock experienced a staggering drop of over 50%, plummeting from $67.69 at the close of trading on October 31, 2025 to just $34.29 by November 3, 2025. Such a drastic fall reflects the erosion of investor confidence and raises concerns about the company's ability to move forward with AMT-130.

The Role of Kessler Topaz Meltzer & Check, LLP

Kessler Topaz Meltzer & Check, LLP is known for its focus on representing individual and institutional investors in securities-fraud class actions. The firm has been recognized for its significant recoveries in securities litigation and aims to uncover any wrongdoing associated with this incident. They encourage any investors affected by these developments to reach out and find out more about their rights and potential actions.

Background on uniQure

uniQure, based in the Netherlands, is known for its pioneering work in gene therapy. However, this recent setback has cast a shadow over the company’s prospects. With AMT-130 being a pivotal project in their pipeline, the uncertainty surrounding the BLA submission timeline has left investors questioning the company's future. The FDA's recent feedback indicates a stark misalignment between the company's expectations and the regulatory body’s requirements, which complicates the landscape for uniQure moving forward.

Next Steps for Investors

If you're an investor who has suffered significant losses due to the decline of uniQure's stock, now may be the time to take action. Kessler Topaz Meltzer & Check invites affected parties to fill out an online form or contact them directly to learn more about the investigation and how they might be able to assist in recovering losses. Their expertise in handling securities cases is well established, and they aim to hold companies accountable for their legal obligations to investors.

Conclusion

As the situation unfolds, it remains crucial for uniQure investors to stay updated on the ongoing investigation and any potential legal recourse available to them. The investigation by Kessler Topaz Meltzer & Check is a significant step towards clarity amidst uncertainty, and it serves as a reminder of the importance of maintaining vigilance when investing in the biotech sector.

For additional information and to get in touch with the legal team, investors can visit the Kessler Topaz Meltzer & Check, LLP website or make direct contact via provided details. It is essential to remain proactive in seeking justice and safeguarding investments during these turbulent times.