Recent Updates
Recently added Catalysts
QURE Negative Sentiment Score: 25/100

uniQure Notice of Investigation: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the Firm

Key Takeaway: Kessler Topaz Meltzer & Check, LLP is investigating uniQure N.V. for potential violations of federal securities laws following a significant stock price drop. On November 3, 2025, uniQure announced that the FDA found its AMT-130 gene therapy data insufficient for a Biologics License Application. As a result, the company faced over a 50% decline in stock value, and uncertainties arose regarding the timing of future BLA submissions for AMT-130.

Market Sentiment Analysis

CONCERNS & RISKS

  • uniQure's stock price fell over 50%, a significant drop.
  • The FDA stated that data for AMT-130 was inadequate for BLA submission.
  • The timing for the BLA submission for AMT-130 is now uncertain.

Full Press Release Details

RADNOR, Pa., Dec. 24, 2025 (GLOBE NEWSWIRE) -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) is currently investigating potential violations of the federal securities laws on behalf of investors of uniQure N.V. (NASDAQ: QURE) (“uniQure”).
On November 3, 2025, uniQure issued a press release revealing that the FDA notified the company that data for its AMT-130, an investigational gene therapy for Huntington’s disease, did not provide sufficient evidence to support uniQure’s Biologics License Application (“BLA”) submission. Specifically, uniQure disclosed that the company believes the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 may be adequate to provide the primary evidence in support of a BLA submission, and that the timing of the BLA submission for AMT-130 is now unclear as a result.
On this news, the price of uniQure’s stock fell over 50%, from a close of $67.69 on October 31, 2025, to close at $34.29 on November 3, 2025.
If you are a uniQure investor and would like to learn more about our investigation, please CLICK HERE to fill out our online form or contact Kessler Topaz Meltzer & Check, LLP: Jonathan Naji, Esq. (484) 270-1453 or E-mail at info@ktmc.com. You can also click on the following link or paste it in your browser: https://www.ktmc.com/uniqure-nv-investigation?utm_source=Globe&mktm=PR
Please CLICK HERE to view our video or copy and paste this link into your browser: https://youtube.com/shorts/MPTaI5yN0zw?feature=share
Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world.  The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars).  For more information about Kessler Topaz Meltzer & Check, LLP, please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
280 King of Prussia Road
May be considered attorney advertising in certain jurisdictions. Past results do not guarantee future outcomes.

Tags

Frequently Asked Questions

What is the investigation by Kessler Topaz about?

Kessler Topaz is investigating potential federal securities law violations for uniQure N.V. investors.

What did uniQure announce on November 3, 2025?

uniQure announced the FDA deemed its AMT-130 data insufficient for a BLA submission.

How did uniQure's stock react to the FDA news?

uniQure's stock price dropped over 50%, closing at $34.29 from $67.69.

How can investors learn more about the investigation?

Investors can contact Kessler Topaz or fill out an online form for more information.

What types of cases does Kessler Topaz handle?

They prosecute class actions involving securities fraud and breaches of fiduciary duty.

Last updated: Dec 24, 2025