Pomerantz Law Firm Investigates Potential Claims for uniQure Investors Amidst FDA Developments

Overview of the Investigation

Pomerantz LLP has launched an investigation on behalf of investors in uniQure N.V., trading under the NASDAQ ticker QURE. The firm seeks to determine if there have been any illegal practices or securities fraud committed by uniQure or its executives.

Background

uniQure is known for its innovative gene therapies, particularly its investigational product AMT-130, designed to treat Huntington's disease. On November 3, 2025, the company issued a press release revealing feedback from the U.S. Food and Drug Administration (FDA) concerning the Biologics License Application (BLA) for AMT-130. The communication from the FDA indicated a significant shift in stance, leading uniQure to believe the data from the Phase I/II studies might no longer suffice for the BLA submission.

This abrupt change has placed the timeline for submitting the BLA into uncertainty. Prior meetings with the FDA had suggested a more favorable outlook, making this new feedback quite unexpected and alarming for investors.

Market Reaction

Following the release of this concerning information, uniQure's stock plummeted by $33.40, representing a 49.34% decrease, closing at $34.29 per share on the same day. This steep decline has sparked fears among investors who may have acted based on the previous communications from the company.

About Pomerantz LLP

Founded by the late Abraham L. Pomerantz, who is often referred to as the dean of the class action bar, Pomerantz LLP has built a strong reputation over its 85 years in the industry. The firm specifically specializes in areas like corporate and securities litigation, ensuring that the rights of victims of corporate misconduct and securities fraud are upheld. Pomerantz has successfully recovered significant damages for class members in various cases. Their extensive reach includes offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv.

Investor Advisory

Pomerantz advises any affected investors of uniQure to contact the firm directly. Danielle Peyton can be reached via email at [email protected] or by phone at 646-581-9980, ext. 7980. They are currently seeking information regarding the circumstances around the alleged securities misrepresentation and how it may have impacted investor decisions.

Conclusion

The investigation is still in its early stages, and as updates emerge, more information will be available to the public and potential claimants. Stakeholders are encouraged to remain vigilant and to seek professional guidance regarding their investment in uniQure. The firm is committed to representing those who may have been harmed by the unpredictable fluctuations in uniQure’s stock and the uncertainties surrounding its regulatory pathway for AMT-130.

For continuous updates on this situation and for other legal inquiries concerning corporate misconduct, investors can turn to Pomerantz's dedicated team, which is ready to assist during this challenging time.