1. uniQure's AMT-130 BLA submission faces FDA rejection due to inadequate evidence. 2. Stock price dropped over 50% following the FDA notification. 3. Kessler Topaz Meltzer & Check is investigating potential securities law violations. 4. The timing for BLA submission is now uncertain, affecting investor confidence. 5. Investors may face legal action due to significant stock price decline.
FAQ
Why Very Bearish?
The FDA's rejection of the BLA submission severely undermines investor confidence. Historically, similar FDA rejections lead to significant stock declines, as seen with companies like Acorda Therapeutics when their MS drug was denied.
How important is it?
The article highlights severe regulatory challenges for uniQure, which considerably affects its stock outlook. With such a significant stock drop and impending investigations, it's crucial for investors to pay attention.
Why Short Term?
Immediate effects are prominent due to rapid stock price response. However, long-term effects will depend on how uniQure addresses the FDA concerns and future submissions.
Investigation Launched Into uniQure N.V. (NASDAQ: QURE) After FDA Notification
RADNOR, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) -- The law firm Kessler Topaz Meltzer & Check, LLP has announced an investigation concerning potential violations of federal securities laws on behalf of investors in uniQure N.V. (NASDAQ: QURE). This inquiry follows a significant announcement made by uniQure on November 3, 2025, regarding its investigational gene therapy product, AMT-130, which targets Huntington’s disease.
FDA's Notification Raises Concerns for BLA Submission
On the specified date, uniQure disclosed that the U.S. Food and Drug Administration (FDA) communicated that the data from clinical studies for AMT-130 did not provide adequate evidence to support the company's Biologics License Application (BLA) submission. According to uniQure, the FDA no longer believes that data from the Phase I/II studies can substantiate the BLA submission, resulting in uncertainty regarding the timing of this application.
Market Reaction and Stock Impact
The reaction to this announcement was immediate and severe. Following the news, the stock price of uniQure plummeted over 50%, closing at $34.29 on November 3, 2025, down from $67.69 on October 31, 2025. This drastic decline highlights the potential impact of regulatory decisions on the valuation of biotech companies like uniQure.
Call to Action for Affected Investors
Investors in uniQure who have sustained significant losses are encouraged to engage with Kessler Topaz Meltzer & Check, LLP for more information about the ongoing investigation. Individuals can fill out an online form or directly contact the firm:
- Contact Person: Jonathan Naji, Esq.
- Phone: (484) 270-1453
- Email: info@ktmc.com
To learn more about the investigation and pursue your legal options, please visit the firm's website: Kessler Topaz Meltzer & Check, LLP - uniQure Investigation.
About Kessler Topaz Meltzer & Check, LLP
Kessler Topaz Meltzer & Check, LLP is committed to prosecuting class actions in both state and federal courts across the United States. The firm specializes in cases involving securities fraud, breaches of fiduciary duties, and violations of applicable laws. Having recovered billions for investors globally, the firm remains a leader in driving corporate governance reform.
For Further Queries
For additional information about Kessler Topaz Meltzer & Check, LLP, visit www.ktmc.com.