Kessler Topaz Investigates uniQure N.V. Amid FDA Concerns Over Gene Therapy Submission

The prominent law firm Kessler Topaz Meltzer & Check, LLP is currently delving into potential federal securities law violations concerning investors in uniQure N.V. (NASDAQ: QURE). This investigation comes in the wake of alarming news regarding uniQure’s investigational gene therapy, AMT-130, which aims to treat Huntington's disease.

On November 3, 2025, uniQure made a press announcement revealing that it received communication from the FDA stating that the data provided for AMT-130 did not offer sufficient evidence to support the company's Biologics License Application (BLA). This revelation marks a significant setback for the company and its stakeholders, as uniQure indicated that the FDA no longer considers the Phase I/II study data to be adequate for a BLA submission. Consequently, the timeline for this submission has become uncertain.

The implications of this notice have had immediate repercussions on the stock market. Following the announcement, uniQure’s shares plummeted by over 50%. The stock, which closed at $67.69 on October 31, 2025, saw a dramatic decline, closing at just $34.29 by November 3, 2025. This steep fall highlights not just the seriousness of the FDA’s concerns but also the potential for significant investor losses.

Kessler Topaz encourages investors who believe they have sustained substantial losses from their investments in uniQure to reach out. Enlightening more about the ongoing investigation and possible legal actions can provide investors with vital information regarding their rights and possible recoveries.

Interested parties can easily access further details by clicking here, or they may contact the firm directly through Jonathan Naji, Esq. at (484) 270-1453 or via email at [email protected].

Kessler Topaz Meltzer & Check, LLP has a robust history of pursuing class action lawsuits across both state and federal courts relating to securities fraud, breaches of fiduciary duty, and numerous violations of both state and federal laws. Their efforts have not only spotlighted issues in corporate governance but also led to substantial recoveries amounting to billions of dollars for both institutional and individual investors globally.

In the wake of such severe stock declines, properly informing affected investors becomes critical. For those who may not be aware, Kessler Topaz represents not just investors but also consumers and whistleblowers—citizens who report fraudulent acts impacting the public sector and subsequently receive a share of any recovered funds. Their comprehensive knowledge in cases such as these can be a beacon for those distressed by recent events surrounding uniQure.

The firm has set forth this investigation with a clear intent to uncover any accountability for losses incurred due to uniQure's circumstances. In a climate where investor trust is paramount, projects like those undertaken by Kessler Topaz serve as crucial reminders for accountability and reform in corporate governance.

For further inquiries or potential claims, investors should not hesitate in reaching out to Kessler Topaz Meltzer & Check, LLP, as they navigate the complexities surrounding securities law on a daily basis.

Conclusion

The unsettling news surrounding uniQure's AMT-130 emphasizes the volatile nature of the biotech sector, especially when regulatory dynamics are involved. Stakeholders are urged to stay informed and proactive about their investments, as the fallout from FDA communications continues to evolve.