uniQure N.V.
Case Overview
| Status: | Status: Investigating |
| Company Name: | Company Name: uniQure N.V. |
| Ticker: | Ticker: QURE |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
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.