1. uniQure's AMT-130 failed to meet FDA data requirements for BLA. 2. Stock price plummeted over 50% after FDA's notification. 3. Kessler Topaz is investigating potential securities law violations. 4. Uncertainty surrounds timing of AMT-130's BLA submission.
FAQ
Why Very Bearish?
The FDA's rejection of crucial data significantly undermines investor confidence, similar to past biotech failures. For example, when a pivotal trial fails, biotech stocks often experience sharp declines as seen with other gene therapy companies.
How important is it?
The article addresses a legal investigation directly related to QURE's stock performance and leads to possible negative momentum impacting investor sentiment.
Why Short Term?
The immediate aftermath of a significant FDA communication typically triggers rapid market reactions, as investors reassess risks and timelines frequently within months.
uniQure N.V. (NASDAQ: QURE) Faces SEC Scrutiny Amidst FDA Announcement
RADNOR, Pa., Dec. 14, 2025 (GLOBE NEWSWIRE) -- The renowned law firm Kessler Topaz Meltzer & Check, LLP is conducting an investigation into potential violations of federal securities laws concerning investors of uniQure N.V. (NASDAQ: QURE), following a recent announcement that has triggered significant stock market movements.
FDA's Notification and Its Immediate Impact on Stock
On November 3, 2025, uniQure revealed that the U.S. Food and Drug Administration (FDA) had notified the company regarding its investigational gene therapy, AMT-130, intended for the treatment of Huntington’s disease. The FDA stated that the data presented did not provide adequate evidence to support uniQure’s Biologics License Application (BLA) submission.
This unexpected development has raised concerns as uniQure indicated that the FDA no longer supports the notion that data from the Phase I/II studies of AMT-130 could serve as primary evidence for the BLA. Consequently, the timeline for the BLA submission of AMT-130 remains uncertain.
Significant Stock Price Decline
The announcement had a dramatic effect on uniQure's stock, resulting in a substantial drop of over 50%. The stock price plummeted from a closing price of $67.69 per share on October 31, 2025, to a closing price of $34.29 on November 3, 2025. This significant decline has raised questions among investors regarding the viability of AMT-130 and the firm's future prospects.
Kessler Topaz Meltzer & Check, LLP's Role
As part of their investigation, Kessler Topaz Meltzer & Check, LLP is encouraging investors who have incurred significant losses in uniQure to reach out for further information. The firm specializes in prosecuting class actions across state and federal courts, handling cases related to securities fraud, fiduciary duty breaches, and additional violations of federal and state laws.
Potential affected investors are urged to contact Jonathan Naji, Esq. at (484) 270-1453 or via email at info@ktmc.com. For further assistance, interested parties can fill out an online form on the law firm’s website or view more insights through their video content.
About Kessler Topaz Meltzer & Check, LLP
Kessler Topaz Meltzer & Check, LLP is recognized for its commitment to corporate governance reform and has successfully recovered billions for investors globally. The firm also advocates for consumers and whistleblowers who report fraudulent activities.
For additional information about the investigation into uniQure (NASDAQ: QURE) or to learn more about the firm's services, please visit www.ktmc.com.