uniQure N.V. Files 8-K Report

TL;DR

uniQure filed an 8-K, likely containing financial updates and other disclosures.

AI Summary

On November 3, 2025, uniQure N.V. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates that uniQure N.V. has submitted required disclosures to the SEC, which may contain updates on corporate events or financial information relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report with no immediate indication of significant negative events or financial distress.

Key Players & Entities

• uniQure N.V. (company) — Registrant
• November 3, 2025 (date) — Date of Report
• The Netherlands (location) — Jurisdiction of Incorporation
• 001-36294 (other) — Commission File Number
• Paasheuvelweg 25a, 1105 BP Amsterdam (address) — Principal Executive Offices

FAQ

Filing Documents

• qure-20251103x8k.htm (8-K) — 41KB
• qure-20251103xex99d1.htm (EX-99.1) — 21KB
• qure-20251103xex99d1001.jpg (GRAPHIC) — 5KB
• 0001104659-25-105223.txt ( ) — 182KB
• qure-20251103.xsd (EX-101.SCH) — 3KB
• qure-20251103_lab.xml (EX-101.LAB) — 15KB
• qure-20251103_pre.xml (EX-101.PRE) — 10KB
• qure-20251103x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 3, 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, following the Company's pre-Biologics License Application (" BLA ") meeting with the United States Food and Drug Administration (the " FDA "). 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 November 3, 2025, the Company announced that, although final meeting minutes have not yet been received, based on the discussions at the pre-BLA meeting, 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. Consequently, the timing of the BLA submission for AMT-130 is now unclear.

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 timing of the Company's BLA submission for AMT-130 and the Company's belief that the FDA currently no longer agrees that data from the ongoing Phase I/II studies of AMT-130 in comparison to an external control may be adequate to provide the primary evidence in support of a BLA submission. 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 more patient data become available that results in a different interpretation than 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 continue to be viewed as robust and sensitive measurements of disease progression; whether Regenerative Med

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 November 3, 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: November 3, 2025 By: /s/ Jeannette Potts JEANNETTE POTTS Chief Legal and Compliance Officer

View Full Filing

View this 8-K filing on SEC EDGAR