1. Kessler Topaz Meltzer & Check is investigating QURE for possible securities violations. 2. uniQure's AMT-130 failed to support the FDA's BLA submission requirements. 3. uniQure stock dropped over 50% following negative FDA news on November 3. 4. The timing of AMT-130's BLA submission is currently unclear.
FAQ
Why Very Bearish?
The significant drop in stock price reflects investor concerns about regulatory failures; similar drops in biotech stocks often precede prolonged recovery times, as seen in similar cases such as that of ACADIA Pharmaceuticals.
How important is it?
The article highlights a critical regulatory setback that could continue to affect investor confidence and stock price, warranting a high importance score.
Why Short Term?
Immediate investor sentiment and stock price reaction are typically influenced by FDA decisions; however, long-term recovery depends on future data transparency and regulatory engagements.
uniQure Faces Investigation by Kessler Topaz Meltzer & Check, LLP Amidst FDA Concerns
On December 24, 2025, Kessler Topaz Meltzer & Check, LLP announced an investigation into potential violations of federal securities laws affecting investors of uniQure N.V. (NASDAQ: QURE). This notice follows a critical disclosure from uniQure regarding regulatory issues surrounding their investigational gene therapy, AMT-130, aimed at treating Huntington's disease.
FDA's Notification on AMT-130's BLA Submission
On November 3, 2025, uniQure publicly stated that the FDA had communicated concerns indicating that data from its Phase I/II trials of AMT-130 did not provide sufficient evidence to support its Biologics License Application (BLA). This development has led to uncertainties surrounding the timing of the BLA submission for this promising treatment.
uniQure expressed its belief that the FDA has shifted its stance on the adequacy of the supporting data from these studies, which has significant implications for the company's regulatory pathway and financial outlook.
Impact on uniQure's Stock Price
In response to the FDA's announcement, the market reacted swiftly. The price of QURE shares plummeted by over 50%, falling from a closing price of **$67.69** on October 31, 2025, to **$34.29** by November 3, 2025. This drastic decline highlights the investor sentiment and concerns surrounding the viability of AMT-130's approval.
How Affected Investors Can Respond
If you are an investor in uniQure and have experienced significant losses, Kessler Topaz Meltzer & Check, LLP encourages you to reach out for support. Interested parties can fill out an online form or contact them directly.
- Contact: Jonathan Naji, Esq.
- Phone: (484) 270-1453
- Email: info@ktmc.com
- Website: Kessler Topaz Meltzer & Check, LLP
Kessler Topaz Meltzer & Check, LLP: A Commitment to Investor Rights
Kessler Topaz Meltzer & Check, LLP is recognized for advocating on behalf of investors in cases involving securities fraud and breaches of fiduciary duty. With a track record of recovering billions for both institutional and individual investors globally, the firm has become a leader in corporate governance reform.
For more information about the firm's efforts and their ongoing investigations, visit www.ktmc.com.