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EX-99.1 - EX-99.1 - Ultragenyx Pharmaceutical Inc.d287475dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): November 11, 2016

 

 

ULTRAGENYX PHARMACEUTICAL INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware

 

001-36276

 

27-2546083

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

60 Leveroni Court,

Novato, California

 

94949

(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (415) 483-8800

Not Applicable

(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:

 

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))

 

 

 


Item 8.01 Other Events.

On November 11, 2016, Ultragenyx Pharmaceutical Inc. issued a press release announcing the withdrawal of its Marketing Authorization Application from the European Medicines Agency for Aceneuramic Acid Prolonged Release (Ace-ER) for the treatment of adult patients with GNE Myopathy. A copy of the press release announcing the withdrawal is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

  

Description

99.1    Press Release dated November 11, 2016

*        *        *

 

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SIGNATURE

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.

Date: November 14, 2016

 

ULTRAGENYX PHARMACEUTICAL INC.
By:   /s/ Shalini Sharp
Name:   Shalini Sharp
Title:   Executive Vice President, Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Press Release, dated November 11, 2016

 

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