uniQure details planned FDA Type A meeting

uniQure N.V. filed a current report describing a communication milestone with U.S. regulators.

Accepted by SEC EDGAR 01/09/2026 - 07:06 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

uniQure N.V. filed a current report describing a communication milestone with U.S. regulators. On January 9, 2026, the company announced via press release that a Type A meeting with the U.S. Food and Drug Administration has been scheduled. This type of meeting is typically used to discuss important regulatory issues for a product or development program. The press release with further details is included as Exhibit 99.1 and is treated as information that is furnished, not filed, under securities law.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did uniQure (QURE) disclose in this Form 8-K?

uniQure disclosed that a Type A meeting with the U.S. Food and Drug Administration has been scheduled and that it issued a press release about this development, furnished as Exhibit 99.1.

Which SEC item does uniQure (QURE) use for this disclosure?

The information is provided under Item 7.01, Regulation FD Disclosure, which is used for important public information that is furnished rather than filed.

How is the press release related to uniQure’s (QURE) 8-K?

The press release announcing the scheduled Type A FDA meeting is attached as Exhibit 99.1 and is incorporated into the report by reference, but only as furnished information.

Is the information in this uniQure (QURE) 8-K considered filed with the SEC?

The company states that the information in Item 7.01 and Exhibit 99.1 is deemed “furnished” and not “filed” for purposes of Section 18 of the Exchange Act.

Does this uniQure (QURE) 8-K include any financial statements?

Under Item 9.01, the company lists only exhibits, including the press release and the cover page interactive data file; it does not include financial statements.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

00-00000000001590560false00015905602026-01-092026-01-09

​

​

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): January 9, 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 7.01                        Regulation FD Disclosure.

On January 9, 2026, uniQure N.V. (the “Company”) issued a press release announcing that a Type A meeting with the U.S. Food and Drug Administration has been scheduled. 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.

​

Item 9.01                        Financial Statements and Exhibits.

(d)            Exhibits.

Exhibit No.	​ ​	Description
99.1		Press Release of uniQure N.V. dated January 9, 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 hereunto duly authorized.

	​
	​ ​ ​	UNIQURE N.V.
	​
	​
Date: January 9, 2026	​	By:	/s/ Jeannette Potts
	​		JEANNETTE POTTS
	​		Chief Legal and Compliance Officer

​

​

​