Information
The law firm of Kirby McInerney LLP reminds investors its investigation on behalf of uniQure N.V. ("uniQure" or the "Company") (NASDAQ:QURE) investors concerning the Company's and/or members of its senior management's
Original sourceAI Summary
uniQure N.V. is under scrutiny for possible violations of federal securities laws. The FDA has raised concerns about the adequacy of data for the AMT-130 BLA submission, leading to a significant drop in share price.
Trading Thesis
QURE's stock remains highly volatile amid FDA concerns and ongoing investigations.
Market-Moving
- QURE stock plummeted 49.3% after FDA's statement on AMT-130.
- Potential legal action could deter new investors from buying QURE.
- Reduced confidence in AMT-130 affects future partnership opportunities.
- Investigation outcomes may lead to further stock price volatility.
- Market sentiment around biopharma may swing on QURE's developments.
Key Facts
- uniQure's stock fell from $67.69 to $34.29 in November.
- The investigation is led by Kirby McInerney LLP.
- uniQure's AMT-130 therapy is for Huntington's disease.
- FDA expressed doubts about AMT-130 data adequacy.
- The investigation involves the company's senior management.
Companies Mentioned
- uniQure N.V. (QURE): Facing potential legal issues affecting stock performance.
- Kirby McInerney LLP: Law firm conducting investigation on QURE-related practices.
Corporate Developments
The news falls under Corporate Developments due to its focus on investigations linked to potential violations of securities laws. Such legal issues can significantly impact investor confidence and stock prices in the biotech sector.
FAQ
Why Very Bearish?
The announcement of the FDA's concerns and the subsequent investigation have led to a sharp drop in QURE's stock price. This reflects a profound lack of investor confidence, reminiscent of past events where regulatory scrutiny has resulted in prolonged declines for biopharma stocks.
How important is it?
The article directly impacts QURE by highlighting legal issues and FDA concerns, which significantly affect investor confidence and market dynamics. High volatility and legal scrutiny are critical factors likely to influence trading decisions among current and prospective investors.
Why Short Term?
The immediate effects of the FDA's announcement and the ongoing investigation are likely to create volatile trading conditions, affecting QURE's share price in the near term due to market reactions and investor sentiment.
The law firm of Kirby McInerney LLP reminds investors its investigation on behalf of uniQure N.V. ("uniQure" or the "Company") (NASDAQ:QURE) investors concerning the Company's and/or members of its senior management's possible violation of the federal securities laws or other unlawful business practices.
[LEARN MORE ABOUT THE INVESTIGATION]
What Happened?
On November 3, 2025, uniQure disclosed that the Company "believes that the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission." The Company added, "Consequently, the timing of the BLA submission for AMT-130 is now unclear." On this news, the price of uniQure shares declined by $33.40 per share, or approximately 49.33%, from 67.69 per share on October 31, 2025 to close at $34.29 on November 3, 2025.
What Should I Do?
If you purchased or otherwise acquired uniQure securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.
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Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260105603922/en/
Kirby McInerney LLP
Lauren Molinaro, Esq.
212-699-1171
https://www.kmllp.com
https://securitiesleadplaintiff.com/
investigations@kmllp.com