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EX-99.1 - EX-99.1 - uniQure N.V.a19-3261_1ex99d1.htm

 

 

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 22, 2019

 

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: +31-20-566-7394

 

 

(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):

 

o                          Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                          Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                          Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                          Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR  240.13e-4(c))

 

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 o

 

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. o

 

 

 


 

Item 8.01.                                        Other Events

 

On January 22, 2019, the Company issued a press release, a copy of which is attached as Exhibit 99.1 and is incorporated herein by reference, announcing that the FDA completed its review of the Company’s Investigational New Drug application for AMT-130 in Huntington’s disease, which is now effective.

 

Item 9.01                                           Financial Statements and Exhibits

 

(d)                                 Exhibits

 

99.1

 

Press release dated January 22, 2019, announcing FDA clearance of Investigational New Drug application for AMT-130 in Huntington’s disease.

 

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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: January 22, 2019

By:

/S/ MATTHEW KAPUSTA

 

 

Matthew Kapusta

 

 

Chief Executive Officer and interim Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit
No.

 

GRAPHICDesciption

99.1

 

Press release dated January 22, 2019, announcing FDA clearance of Investigational New Drug application for AMT-130 in Huntington’s disease.

 

4