Form 8-K

8-K — uniQure N.V.

Accession: 0001104659-26-074853

Filed: 2026-06-17

Period: 2026-06-17

CIK: 0001590560

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.

20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

June 17, 2026

uniQure

N.V.

(Exact Name of Registrant as Specified in Charter)

The Netherlands

001-36294

N/A

(State or Other

Jurisdiction of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

Paasheuvelweg

25a,

1105 BP Amsterdam,

The Netherlands

N/A

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including

area code: +31-20-240-6000

(Former Name or Former Address, if Changed Since

Last Report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities

Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant

to Section 12(b) of the Act:

Title of each class:

Trading

Symbol(s)

Name of each exchange on which

registered:

Ordinary

Shares, par value €0.05 per share

QURE

The

Nasdaq Stock Market LLC

The Nasdaq Global Select Market

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2

of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

June 17, 2026, uniQure N.V. (the “Company”) issued a press release announcing its plan to submit its

Biologic License Application (“BLA”) for AMT-130 in Huntington’s Disease during the third quarter of

2026. This announcement follows the Company’s recent Type B meeting with the U.S. Food and Drug Administration

(“FDA”) in which the FDA communicated that the 3-year analysis from the Phase I/II study would be

acceptable as the primary basis of a BLA for the accelerated approval of AMT-130 in Huntington’s disease. Prior to submission

of the BLA, the FDA seeks alignment with the Company on the confirmatory study design, including consideration of a concurrent

control of standard of care that would not include a sham procedure. The Company is committed to conducting the confirmatory study

without delay and expects to further align with the FDA on the details of such a study prior to BLA submission. The Company expects

to receive final minutes within 30 days of the Type B meeting.

The press release is attached as Exhibit 99.1

to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.

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 conduct a confirmatory study, including the design,

timing, endpoints and control arm of such study, and to align with FDA on such study prior to BLA submission, the potential use of a

concurrent standard-of-care control arm rather than a sham procedure, and expectations regarding timing of BLA submission and receiving

accelerated approval of AMT-130. 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/II clinical

trials of AMT-130, including the risk that such trials will be unable to continue to demonstrate data sufficient to support further clinical

development or regulatory approval; the risk that the FDA ultimately concludes that the Phase I/II trial data are not sufficient to support

a BLA or accelerated approval; the risk that more patient data become available that results in a different interpretation than the one

derived from the year three data analyses; 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 disease progression; whether RMAT designation, Breakthrough Therapy

designation, or any accelerated pathway, if granted, will lead to regulatory approval; the Company’s ability to conduct and fund

any required confirmatory study for AMT-130; the Company’s ability to successfully complete any required confirmatory study for

AMT-130; the risk that accelerated approval, if granted, may be subject to post-approval requirements that are difficult or costly to

satisfy; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to achieve its goals;

the Company’s effectiveness in managing current and future clinical trials and regulatory processes; the Company’s ability

to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the continued development and acceptance of

gene therapies; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s ability

to fund its operations and to raise additional capital as needed and on acceptable terms. These risks and uncertainties are more fully

described under the heading "Risk Factors" in the Company’s periodic filings with the U.S. Securities & Exchange Commission

(“SEC”), including its Annual Report on Form 10-K filed with the SEC on March 2, 2026, its Quarterly Report on Form

10-Q filed with the SEC on May 5, 2026 and in other filings that the Company makes with the SEC from time to time. Given these risks,

uncertainties and other factors, you should not place undue reliance on these forward-looking statements and, except as required by law,

the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Item 9.01 Financial Statements and Exhibits.

(d)           Exhibits.

Exhibit No.

Description

99.1

Press Release of uniQure N.V. dated June 17, 2026

104

Cover Page Interactive Data File (embedded with the Inline XBRL document).

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, thereunto

duly authorized.

UNIQURE N.V.

Date: June 17, 2026

By:

/s/ Jeannette Potts

JEANNETTE POTTS

Chief Legal and Compliance Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2618105d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

uniQure Announces

Plan for BLA Submission for AMT-130 in

Huntington’s

Disease

~ 3-year analysis from the Phase I/II study

can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ~

~ Company intends to submit the BLA in third

quarter of 2026 ~

Lexington, MA

and Amsterdam, the Netherlands, June 17, 2026 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company

advancing transformative therapies for patients with severe medical needs, today announced that, during a recent Type B meeting with

the U.S. Food and Drug Administration (FDA), the FDA communicated that the 3-year analysis from the Phase I/II study would be acceptable

as the primary basis of a Biologics License Application (BLA) for the accelerated approval of AMT-130 in Huntington’s disease.

In addition, the FDA seeks to align on the confirmatory study design prior to the BLA submission, including consideration of concurrent

control on standard-of-care therapy instead of a sham procedure. FDA communicated that they would work as expeditiously as possible with

uniQure on this effort. The Company is committed to conducting the confirmatory study without delay and expects to further align with

the FDA on the details of such a study prior to BLA submission. The Company intends to submit the BLA in the third quarter of 2026.

"Today's announcement

reflects the outcome we have worked toward throughout our continued regulatory engagement with FDA, and we are deeply grateful for FDA’s

genuine commitment to addressing the unmet need of Americans living with Huntington’s disease," said Matt Kapusta,

chief executive officer at uniQure. "The FDA has agreed that our current clinical data can

support a near-term BLA submission and has committed to work expeditiously with us to align on the design of the required confirmatory

study. The consistency and strength of the clinical data generated to date give us great confidence in the product's potential to make

a meaningful difference for patients. We remain focused on bringing AMT-130 to patients and families as quickly and responsibly as possible

in the US and globally."

The Company expects to receive final minutes within

30 days of the recent Type B meeting.

AMT-130 has been granted Regenerative Medicine

Advanced Therapy (RMAT) designation by the FDA – the first RMAT designation for Huntington’s disease – as well as Breakthrough

Therapy designation and Fast Track designation.

About the Phase I/II Clinical Program of AMT-130

uniQure is conducting two multi-center, dose-escalating,

Phase I/II clinical studies to explore the safety, tolerability, and exploratory efficacy signals of AMT-130 for the treatment of Huntington’s

disease. Based on interactions with the 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 BLA submission.

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 additional 12 patients

across sites in the U.S. and EU. This cohort was randomized to explore both doses of AMT-130 in combination with immunosuppression, using

the current, established stereotactic administration procedure.

A fourth U.S. based cohort enrolled six patients

and is evaluating high-dose AMT-130 in patients with lower striatal volumes compared to those of patients enrolled in previous cohorts.

Additional details

are available on www.clinicaltrials.gov (NCT05243017, NCT04120493)

About Huntington’s Disease

Huntington’s disease is a rare, inherited

neurodegenerative disorder that leads to motor symptoms including chorea, behavioral abnormalities and cognitive decline resulting in

progressive physical and mental deterioration. The disease is an autosomal dominant condition with a disease-causing CAG repeat expansion

in the first exon of the huntingtin gene that leads to the production and aggregation of abnormal protein in the brain. Approximately

75,000 people have Huntington’s disease in the U.S.1, EU2, and the UK3, with hundreds of

thousands of others at risk of inheriting the disease. Despite the clear etiology of Huntington’s disease, there are currently no

approved therapies to delay the onset or to slow the disease’s progression.

About uniQure

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

uniQure Forward-Looking Statements

This press release 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 conduct a confirmatory

study, including the design, timing, endpoints and control arm of such study, and to align with FDA on such study prior to BLA submission,

the potential use of a concurrent standard-of-care control arm rather than a sham procedure, and expectations regarding timing of BLA

submission and receiving accelerated approval of AMT-130. 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/II clinical trials of AMT-130, including the risk that such trials will be unable to continue to demonstrate data sufficient to

support further clinical development or regulatory approval; the risk that the FDA ultimately concludes that the Phase I/II trial data

are not sufficient to support a BLA or accelerated approval; the risk that more patient data become available that results in a different

interpretation than the one derived from the year three data analyses; 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 disease progression; whether RMAT designation,

Breakthrough Therapy designation, or any accelerated pathway, if granted, will lead to regulatory approval; the Company’s ability

to conduct and fund any required confirmatory study for AMT-130; the Company’s ability to successfully complete any required confirmatory

study for AMT-130; the risk that accelerated approval, if granted, may be subject to post-approval requirements that are difficult or

costly to satisfy; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to achieve its

goals; the Company’s effectiveness in managing current and future clinical trials and regulatory processes; the Company’s

ability to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the continued development and acceptance

of gene therapies; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s ability

to fund its operations and to raise additional capital as needed and on acceptable terms. These risks and uncertainties are more fully

described under the heading "Risk Factors" in the Company’s periodic filings with the U.S. Securities & Exchange

Commission (“SEC”), including its Annual Report on Form 10-K filed with the SEC on March 2, 2026, its Quarterly

Report on Form 10-Q filed with the SEC on May 5, 2026 and in other filings that the Company makes with the SEC from time to

time. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements and,

except as required by law, the Company assumes no obligation to update these forward-looking statements, even if new information becomes

available in the future.

uniQure Contacts:

FOR INVESTORS:

FOR MEDIA:

Chiara Russo

Tom Malone

Direct: 781-491-4371

Direct: 339-970-7558

Mobile: 617-306-9137

Mobile:339-223-8541

c.russo@uniQure.com

t.malone@uniQure.com

Yohrling G, et al. Neurology 2020;94(15 Suppl):954.

Medina A, et al. Mov Disord 2022;37(12):2327–2335

Furby H, et al. Eur J Neurol 2022;29(8):2249–2257.

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