uniQure N.V. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
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Item 7.01 Regulation FD Disclosure.
On June 2, 2025, uniQure N.V. (the “Company”) issued a press release announcing that it had reached alignment with the U.S. Food and Drug Administration on several key components of the statistical analysis plan and Chemistry, Manufacturing and Controls information that will support a Biologics License Application submission for AMT-130, the Company’s investigational gene therapy for the treatment of Huntington’s disease. The Company also announced that it will host an investor call and webcast beginning at 8:30 a.m. Eastern Time on the same date, during which the Company will discuss these updates. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The virtual event can be accessed via the Events and Presentations section of the Company’s website at https://www.uniqure.com/investors-media/events-presentations, and will be available for replay for 90 days following the event. The Company’s website and any information contained on the website are not incorporated into this Current Report on Form 8-K.
The information provided in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of uniQure N.V. dated June 2, 2025. | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| UNIQURE N.V. | ||
| Date: June 2, 2025 | By: | /s/ Jeannette Potts |
| JEANNETTE POTTS | ||
| Chief Legal and Compliance Officer | ||