Ordinary Shares, par value €0.05 per share
- Symbol
- QURE
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
uniQure N.V.
QURENASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On September 29, 2026, uniQure N.V. (the “ Company ”) presented an update of its ongoing clinical trials of AMT-130 (the “Presentation”) and issued a press release which summarizes the Presentation (the “Release”). Copies of the Presentation and Release are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated into this Item 7.01 by reference.…
Company context
uniQure is delivering on the promise of gene therapy - single treatments with potentially curative results. The approvals of uniQure’s gene therapy for hemophilia B - an historic achievement based on more than a decade of research and clinical development - represent a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. uniQure is now advancing a pipeline of proprietary gene therapies for the treatment of patients with Huntington's disease, refractory temporal lobe epilepsy, Fabry disease, and other severe diseases. www.uniQure.com
Current securities
Registered securities in this filing
uniQure N.V. · 8-K · Filed 2026-09-29
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On
September 29, 2026, uniQure N.V. (the “ Company ”) presented an update of its ongoing clinical trials of AMT-130
(the “Presentation”) and issued a press release which summarizes the Presentation (the “Release”).
Copies of the Presentation and Release are
furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated into this Item 7.01 by reference.
The information in this Item 7.01 of this
Current Report on Form 8-K, the Presentation and the Release, shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the
Securities Act of 1933, as amended. The information contained in this Item 7.01, and in the Presentation and the Release, shall not be
incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after
the date hereof, regardless of any general incorporation language in such filing.
Filed exhibits (2)
Exhibit 99.1 Ashley – Huntington’s Disease Community Advocate Phase I/II ifezuntirgene inilparvovec (AMT-130) Huntington’s Disease Program Update September 29, 2026 ──────────────────────────── LEADERSHIP IN GENE THERAPY SEPTEMBER 2026 | 2 This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” "will,” “would” and similar expressions and the negatives of those terms. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this presentation. Examples of these forward-looking statements include, but are not limited to, statements concerning: the timing of our meetings and discussions with regulatory authorities; our ability to continue accumulating …
Open exhibit ↗Exhibit 99.2 uniQure Announces Additional Data from Ongoing Phase I/II Studies of ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease Showing Continued Slowing of Disease Progression ~ In 12 high-dose patients at 48 months, both cUHDRS and TFC continued to demonstrate meaningful slowing of disease progression and clear dose-dependent response; the primary endpoint of cUHDRS showed 44% slowing of disease progression (non-significant p=0.144) and TFC showed a 61% slowing of disease progression (nominal p=0.008) ~ ~ Updated data reflecting all 15 high-dose patients showed substantial treatment effect on both cUHDRS and TFC at 36 months, the timepoint that is the regulatory anchor for the submitted BLA and the confirmatory study; the new analysis demonstrated 80% slowing of disease progression based on cUHDRS (nominal p=0.005) and 67% based on TFC (nominal p=0.011) ~ ~ Treatment effect at 48 months likely understated by substantial missing data and survivor bias in updated external control; post hoc analysis using prior external control showed slowing of disease of 54% on cUHDRS (nominal p=0.041) and 68% on TFC (nominal p=0.001) at 48 months ~ ~ These positive data are me…
Open exhibit ↗