1. uniQure's BLA for AMT-130 is in jeopardy due to FDA concerns. 2. Stock fell 50% after FDA's negative feedback on AMT-130 data. 3. Kessler Topaz is investigating potential securities law violations for investors. 4. Uncertainty around AMT-130's development may hinder future investments. 5. Investor confidence likely shaken due to regulatory setbacks.
FAQ
Why Very Bearish?
The recent 50% drop signals deep investor concern and perceived regulatory risk, akin to past biotech failures.
How important is it?
Regulatory setbacks typically lead to significant price declines in biotech stocks like QURE.
Why Short Term?
The immediate response to FDA feedback is crucial; recovery may take time contingent on clear guidance.
uniQure N.V. (NASDAQ: QURE) Under Investigation for Potential Securities Violations
The law firm Kessler Topaz Meltzer & Check, LLP is conducting an investigation into possible violations of federal securities laws on behalf of investors in uniQure N.V. (NASDAQ: QURE). This inquiry has been prompted by a recent press release issued by uniQure on November 3, 2025, concerning its investigational gene therapy, AMT-130, intended for the treatment of Huntington's disease.
FDA Notification Raises Concerns for uniQure Investors
In its press release, uniQure disclosed that the U.S. Food and Drug Administration (FDA) determined the data submitted for AMT-130 was insufficient to support the company’s Biologics License Application (BLA) submission. The firm indicated that the FDA no longer considers data from the Phase I/II studies adequate to provide primary evidence for the BLA. Consequently, the timeline for the BLA submission for AMT-130 remains uncertain, raising alarms for investors.
Impact on Stock Price
This adverse news had a drastic effect on uniQure's stock performance. The shares plummeted over 50%, falling from a close of $67.69 on October 31, 2025, to a closing price of $34.29 on November 3, 2025. This significant drop reflects investor concerns over the viability of AMT-130 and the implications for the company’s future.
Investor Guidance and Legal Support
Kessler Topaz Meltzer & Check, LLP is urging current investors of uniQure who have experienced substantial losses to reach out for a consultation regarding their rights. Investors can fill out an online form or contact attorney Jonathan Naji at (484) 270-1453 or via email at jnaji@ktmc.com for more information.
About Kessler Topaz Meltzer & Check, LLP
Kessler Topaz Meltzer & Check, LLP, commonly referred to as KTMC, is a prominent U.S.-based law firm specializing in securities fraud class actions and global investor protection. The firm represents both individual and institutional investors, including major pension funds and asset managers. Notably, KTMC has achieved substantial recoveries in securities litigation and has received numerous accolades, including being listed in The National Law Journal's Plaintiff’s Hot List and Law360's Titans of the Plaintiffs Bar.
For more information about KTMC and its services, visit www.ktmc.com.
Contact Information
For more inquiries related to the investigation concerning uniQure N.V. (NASDAQ: QURE), please reach out to:
- Jonathan Naji, Esq.
- 280 King of Prussia Road
- Radnor, PA 19087
- Phone: (484) 270-1453
- Email: jnaji@ktmc.com
Please note: The information provided may be considered attorney advertising in some jurisdictions. Prior results do not guarantee similar outcomes.