Ordinary Shares, par value €0.05 per share
- Symbol
- QURE
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
uniQure N.V.
QURENASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure. On June 19, 2026, uniQure N.V. (the “Company”) issued a press release announcing preliminary data on the first cohort in the Company’s Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy. 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.…
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 2026-06-22
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01
Regulation FD Disclosure.
On June 19, 2026, uniQure N.V. (the “Company”) issued a press release announcing preliminary data on the first cohort in the Company’s Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy. 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, 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.
Item 8.01Item 8.01 - Other Events
Item 8.01
Other Events.
On June 19, 2026, the Company announced preliminary data on the first cohort in the Company’s Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy. As of the May 29, 2026 data cutoff date, three of six patients in the first, low-dose cohort (1x1012 gc/mL) achieved meaningful reductions in disabling seizures during months four through six of follow-up, ranging from a 79% to 100% decline from baseline. The remaining three patients in the low-dose cohort experienced variable changes in disabling seizures during months four through six of follow-up, ranging from a 33% decrease to a 36% increase compared to baseline. As of June 19, 2026, there have been no serious adverse events related to AMT-260 or the surgical procedure reported. All reported adverse events in the low dose cohort were classified as mild or moderate in severity, with the most common adverse event being headache (N=2). No immunosuppression was required.
Filed exhibits (1)
EX-99.1 2 qure-20260619xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces Preliminary Data on the First Cohort in the Phase I/IIa Clinical Trial of AMT-260 in Refractory Mesial Temporal Lobe Epilepsy ~ AMT-260 was generally well-tolerated with no serious adverse events observed to date, with early biological signals of potential therapeutic activity ~ Lexington, MA and Amsterdam, the Netherlands, June 19, 2026 - uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced initial six-month follow-up data on the first, low dose cohort of six patients in its ongoing Phase I/IIa trial of an investigational gene therapy candidate, AMT-260, for the treatment of refractory mesial temporal lobe epilepsy (MTLE). The data will be presented today, Friday, June 19, 2026, at the Epilepsy Foundation Pipeline Conference in Leesburg, VA. As of the May 29, 2026 data cutoff date, three of six patients in the first, low-dose cohort (1x1012 gc/mL) achieved meaningful reductions in disabling seizures during months four through six of follow-up, ranging from a 79% to 100% decline from baseline. The remaini…
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