#United States #New York #FDA Approval #Securities Fraud #uniQure N.V.

uniQure N.V. Faces Legal Challenges Over FDA Approval

In a significant move, Kahn Swick & Foti, LLC, a prominent law firm specializing in securities litigation, has announced a class action lawsuit against uniQure N.V. This follows a sharp 49% decline in its stock price, attributed largely to delays associated with the company's FDA approval processes.

Background of the Case

From September 24, 2025, to October 31, 2025, investors who purchased shares of uniQure may have substantial grounds for recourse. The lawsuit alleges that the company misled investors regarding the likelihood of its drug candidate, AMT-130, achieving accelerated approval. This candidate was widely expected to receive such approval after the company's anticipated Biologics License Application (BLA) submission in early 2026.

On November 3, 2025, uniQure disclosed troubling news that the FDA no longer deemed the data from previous clinical studies adequate to support a submission for the BLA. This announcement triggered a drastic fall in the stock price—from $67.69 to $34.29 in a matter of days—resulting in significant financial losses for investors.

The Nature of Allegations

The lawsuit claims that uniQure and certain executives failed to disclose critical information affecting the viability of AMT-130, violating federal securities laws. The lack of transparency regarding the FDA's stance on the drug's clinical trial data raises important questions about the company's communication to its shareholders.

Many investors, under the false impression that the drug would gain quick approval, may have made significant financial commitments only to see their investments plummet overnight.

Filing Deadline

For investors looking to join the class action, the deadline for filing applications as lead plaintiffs is April 13, 2026. Interested parties can contact Lewis Kahn at Kahn Swick & Foti, LLC, for consultations regarding their legal rights and potential avenues for compensation.

Law Firm's Reputation

Kahn Swick & Foti, LLC, led by former Louisiana Attorney General Charles C. Foti, Jr., is known for championing investors' rights. The firm has been recognized nationally for its work in securities litigation, consistently ranking among the top legal firms in this area based on settlement values.

While university investors anticipate positive developments from pharma companies like uniQure, unforeseen setbacks can lead to devastating losses, underscoring the need for caution and diligence when making investment decisions.

Conclusion

As this situation develops, investors are urged to stay informed and consider their options for recourse. With the complexities surrounding FDA approvals and stock market impacts, the case against uniQure serves as a critical reminder of the volatile nature of the pharmaceutical investment landscape. Individuals are encouraged to seek legal advice to understand their rights and navigate the landscape of securities litigation amidst such significant turns of events.