uniQure N.V.
Case Overview
57 Days Left to Seek Lead Plaintiff
| Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 04/13/2026 |
| Status: | Status: Investigating |
| Company Name: | Company Name: uniQure N.V. |
| Court: | Court: Southern District of New York |
| Case Number: | Case Number: 1:26cv01124 |
| Class Period: | Class Period: 09/24/2025 - 10/31/2025 |
| Ticker: | Ticker: QURE |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired uniQURE N.V. (“uniQURE” or the “Company”) (NASDAQ:QURE) securities during the period of September 24, 2025 through October 31, 2025, inclusive (“the Class Period”).
The lawsuit alleges that (1) the design of uniQURE’s Pivotal Study including comparison of the Pivotal Study results to the ENROLL-HD external historical data set was not fully approved by the FDA and (2) the Company downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQURE would have to delay its BLA timeline to perform additional studies to supplement its BLA submission.
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.
The lawsuit alleges that (1) the design of uniQURE’s Pivotal Study including comparison of the Pivotal Study results to the ENROLL-HD external historical data set was not fully approved by the FDA and (2) the Company downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQURE would have to delay its BLA timeline to perform additional studies to supplement its BLA submission.
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.