Uniqure N.V. 8-K Filing

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• qure-20251204x8k.htm (8-K) — 41KB
• qure-20251204xex99d1.htm (EX-99.1) — 17KB
• qure-20251204xex99d1001.jpg (GRAPHIC) — 4KB
• 0001104659-25-118292.txt ( ) — 176KB
• qure-20251204.xsd (EX-101.SCH) — 3KB
• qure-20251204_lab.xml (EX-101.LAB) — 15KB
• qure-20251204_pre.xml (EX-101.PRE) — 10KB
• qure-20251204x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 4, 2025, uniQure N.V. (the " Company ") issued a press release announcing a regulatory update on AMT-130, an investigational gene therapy for Huntington's disease. 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 information provided in this Item 7.01, including the accompanying Exhibit 99.1, shall be deemed "furnished" and 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 (the " Securities Act "), or the Exchange Act, regardless of the general incorporation language of such filing, except to the extent that such filing incorporates by reference any or all of such information by express reference.

01 Other Events

Item 8.01 Other Events. On December 4, 2025, the Company announced that the Company received final meeting minutes from the U.S. Food and Drug Administration (the " FDA ") regarding a pre-Biologics License Application (" BLA ") meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington's disease. In the final meeting minutes, the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. The Company is carefully evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "establish," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "seek," "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 report. Examples of these forward-looking statements include, but are not limited to, statements concerning: the Company's plans to request a follow-up meeting with the FDA to take place in the first quarter of 2026, and the timing and outcome of regulatory interactions with respect to the AMT-130 program. The Company's actual results could differ materially from those anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks related to the Company's Phase I/ll clinical trials of AMT-130, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that the FDA ultimately concludes that such trials are not adequate and well-controlled to provide the primary evidence to support a BLA; the risk that more patient data become available that results in a different interpretation then the one derived from the topline data; risks related to the Company's interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval; whether the measurements that the Company is evaluating are viewed as robust and sensitive measurements of dise

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release of uniQure N.V. dated December 4, 2025 104 Cover Page Interactive Data File (embedded with the Inline XBRL document).

SIGNATURES

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 hereunto duly authorized. UNIQURE N.V. Date: December 4, 2025 By: /s/ Jeannette Potts JEANNETTE POTTS Chief Legal and Compliance Officer

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