uniQure N.V. Files 8-K Report

TL;DR

uniQure filed its 8-K, mostly exhibits. Check them for news.

AI Summary

On September 24, 2025, uniQure N.V. filed an 8-K report. The filing primarily consists of financial statements and exhibits, with no specific material events or disclosures detailed in the provided text beyond the standard reporting requirements. The company is incorporated in The Netherlands and its principal executive offices are located in Amsterdam.

Why It Matters

This filing indicates uniQure N.V. is meeting its regulatory reporting obligations. Investors can review the exhibits for any potential updates or disclosures.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report primarily containing financial statements and exhibits, with no immediate material events disclosed.

Key Players & Entities

• uniQure N.V. (company) — Registrant
• September 24, 2025 (date) — Date of earliest event reported
• The Netherlands (location) — Jurisdiction of Incorporation
• Amsterdam (location) — Principal Executive Offices City
• Paasheuvelweg 25a (address) — Principal Executive Offices Street
• 1105 BP (zip_code) — Principal Executive Offices Zip Code

FAQ

Filing Documents

• qure-20250924x8k.htm (8-K) — 55KB
• qure-20250924xex99d1.htm (EX-99.1) — 42KB
• qure-20250924xex99d1001.jpg (GRAPHIC) — 6KB
• 0001104659-25-092740.txt ( ) — 227KB
• qure-20250924.xsd (EX-101.SCH) — 3KB
• qure-20250924_lab.xml (EX-101.LAB) — 15KB
• qure-20250924_pre.xml (EX-101.PRE) — 10KB
• qure-20250924x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On September 24, 2025, uniQure N.V. (the " Company ") issued a press release announcing updates on its ongoing clinical trials of AMT-130, as described in more detail in Item 8.01 below. 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 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 September 24, 2025, the Company announced positive topline data from the pivotal Phase I/II study of AMT-130 for the treatment of Huntington's disease. The topline data include follow-up data from patients enrolled in the Company's two ongoing multi-center, dose-escalating Phase I/II clinical trials in the U.S. and Europe. Based on interactions with the U.S. Food and Drug Administration (" FDA "), it was agreed that data from cohorts 1 and 2 in the Phase I/II studies could be compared to a propensity score-matched external control derived from the Enroll-HD natural history data set, under a prespecified statistical analysis plan, which may serve as the primary basis for a Biologic License Application (" BLA ") submission. Based on these interactions, the ongoing Phase I/II AMT-130 clinical trials are supplemented by two additional protocols, each with a statistical plan that was discussed with and submitted to the FDA. The new protocols, among other things, provide for the pooling of data across the ongoing U.S. and EU studies, and also prespecified the pivotal comparison of AMT-130 clinical end points compared to a propensity score-matched external control from the Enroll-HD natural history data set. In the U.S. study, a total of 26 patients with early manifest Huntington's disease were randomized to treatment (n=6 low dose; n=10 high dose) or an imitation (sham) procedure (n=10). Treated patients received a single administration of AMT-130 through MRI-guided, convection-enhanced stereotactic neurosurgical delivery directly into the striatum (caudate and putamen). The study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of treated patients for five years. An additional four control patients crossed over to treatment. The European open-label Phase 1b/2 study of AMT-130 enrolled 13 patients with early manifest Huntington's disease (n=6 low dose; n=7 high dose). A third cohort enrolled an additi

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 explore AMT-130 in a fourth cohort of up to 6 patients with lower striatal volumes compared to those patients enrolled in previous cohorts; the Company's plans to have a pre-BLA meeting with the FDA later this year, and the Company's plans to submit a BLA for AMT-130 in the first quarter of 2026. 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 topline data may not be predictive of later data readouts; 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 Medicine Advanced Therapy designation

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 September 24, 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: September 24, 2025 By: /s/ Jeannette Potts JEANNETTE POTTS Chief Legal and Compliance Officer

View Full Filing

View this 8-K filing on SEC EDGAR