1. Kirby McInerney LLP is investigating possible violations by uniQURE's management. 2. uniQURE's BLA submission for AMT-130 is now uncertain after FDA feedback. 3. uniQURE shares plummeted 49.33% following the FDA's communication on data adequacy.
The sharp decline in QURE shares reflects significant investor concerns post-FDA announcement, echoing past FDA rejections impacting biotech stocks.
The investigation and recent FDA comments significantly alter the outlook for AMT-130 and investor confidence.
Investors may have a negative sentiment in the immediate future due to uncertainty surrounding AMT-130.
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.
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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.
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Kirby McInerney LLP
Lauren Molinaro, Esq.
212-699-1171
https://www.kmllp.com
https://securitiesleadplaintiff.com/
investigations@kmllp.com