Ordinary Shares, par value €0.05 per share
- Symbol
- QURE
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 2.02, 7.01, 9.01 · 8-K
uniQure N.V.
QURENASDAQEQUITYCurrent
Results of Operations and Financial Condition · Regulation FD Disclosure
Item 2.02 Results of Operations and Financial Condition. On March 2, 2026, uniQure N.V. (the “Company”) issued a press release announcing its financial results for the quarter and full year ended December 31, 2025 and providing a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.…
Press release in this filing
uniQure Announces 2025 Financial Results and Provides Recent Company Updates →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 2026-03-02
Disclosure sections
Item 2.02Item 2.02 - Results of Operations
Item 2.02 Results of Operations and Financial Condition.
On March 2, 2026, uniQure N.V. (the “Company”) issued a press release announcing its financial results for the quarter and full year ended December 31, 2025 and providing a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01
Regulation FD Disclosure.
On March 2, 2026, the Company issued a press release announcing a regulatory update on AMT-130, the Company’s investigational gene therapy for Huntington’s disease. A copy of the press release is being furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished pursuant to this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Filed exhibits (2)
EX-99.1 2 qure-20260302xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces 2025 Financial Results and Provides Recent Company Updates ~ Held Type A meeting with FDA to discuss AMT-130 for Huntington’s disease; Company evaluating Phase III development considerations and plans to request follow-up Type B meeting in the second quarter of 2026 ~ ~ Completed enrollment of the first cohort in the Phase I/IIa study of AMT-260 in refractory mesial temporal lobe epilepsy, with additional clinical data expected in the first half of 2026~ ~ Presented updated Phase I/II data from AMT-191 in Fabry disease showing durable, dose-dependent increases in α-Gal A enzyme activity ~ ~ Cash, cash equivalents and current investment securities of approximately $622.5 million as of December 31, 2025 expected to fund operations into the second half of 2029 ~ ~ uniQure to host earnings call at 8:00 a.m. ET ~ Lexington, MA and Amsterdam, the Netherlands, March 2, 2026 - uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year of 2025 and highlighted …
Open exhibit ↗EX-99.2 3 qure-20260302xex99d2.htm EX-99.2 Exhibit 99.2 uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease Lexington, MA and Amsterdam, the Netherlands, March 2, 2026 - uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a Type A meeting held on January 30, 2026 to discuss AMT-130, an investigational gene therapy for Huntington’s disease (HD). The FDA stated that it cannot agree that data from the Phase I/II studies, compared to an external control, are sufficient to provide the primary evidence of effectiveness required to support a marketing application for AMT- 130. The FDA strongly recommended uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study. uniQure intends to continue engaging with the FDA regarding Phase III development considerations and plans to request a Type B meeting in the second quarter of 2026 to further discuss potential study design approaches. “While we did not reach alignment on a submission path…
Open exhibit ↗