Every material Form 8-K uniQure N.V. has filed with the SEC since September 29, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
uniQure reported third quarter 2026 results with revenue of $5.2 million, up from $3.7 million a year earlier, and a net loss of $61.2 million, or $0.88 per share, versus $80.5 million, or $1.38 per share, in the prior-year quarter. The FDA granted Priority Review to the Biologics License Application for ifezuntirgene inilparvovec in Huntington's disease, with a PDUFA target action date of May 1, 2027, and the company said its $768.4 million in cash and investments is expected to fund operations into 2030.
Revenue was $5.2 million for the quarter ended September 30, 2026, up $1.5 million from $3.7 million, driven by higher license revenue.
Net loss was $61.2 million, or $0.88 per share, compared with $80.5 million, or $1.38 per share, a year earlier.
The FDA granted Priority Review to the BLA for ifezuntirgene inilparvovec with a PDUFA target action date of May 1, 2027.
Cash, cash equivalents and investment securities were $768.4 million as of September 30, 2026, which the company expects to fund operations into 2030.
uniQure N.V. said the FDA accepted its Biologics License Application for ifezuntirgene inilparvovec, an investigational gene therapy for Huntington's disease, and granted Priority Review with a PDUFA target action date of May 1, 2027. The FDA also said it is tentatively planning an Advisory Committee meeting, with dates to be set later, and the company and FDA have aligned on the design of a confirmatory trial.
FDA accepted the BLA under the Accelerated Approval pathway and granted Priority Review
PDUFA target action date is May 1, 2027
FDA tentatively plans to discuss the application at an Advisory Committee meeting; the company will be notified once the date is set
Confirmatory trial design: randomized, standard-of-care, about 200 patients in a 2:1 ratio, Total Functional Capacity at 36 months as primary endpoint; U.S. patient screening planned to start by end of 2026
uniQure presented additional data from its ongoing Phase I/II studies of AMT-130 for Huntington's disease, comparing treated patients with updated external controls. The 36-month analysis of all 15 high-dose patients showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (nominal p=0.011), and the company says the BLA submission was based on 36-month data. The 48-month primary cUHDRS result showed 44% slowing but did not reach statistical significance (p=0.144), and the company notes that missing data and survivor bias in the updated control may understate the treatment effect.
36-month analysis of 15 high-dose patients: 80% slowing of cUHDRS decline (nominal p=0.005) and 67% slowing of TFC decline (nominal p=0.011)
48-month analysis of 12 high-dose patients: 44% slowing on cUHDRS (p=0.144, not significant) and 61% slowing on TFC (nominal p=0.008)
Data missingness in the updated Enroll-HD B control reached 53% at Month 48; data cutoff was June 30, 2026
Company says the BLA was submitted on 36-month data, which the FDA said at a June 2026 Type B meeting would be acceptable under the accelerated approval pathway
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