8-K 1 a16-12704_18k.htm 8-K

 

 

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):  June 2, 2016

 

 

INNOVIVA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware
(State or Other Jurisdiction of
Incorporation)

 

000-30319
(Commission File Number)

 

94-3265960
(I.R.S. Employer Identification Number)

 

951 Gateway Boulevard
South San Francisco, California 94080

(650) 238-9600

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

 

 

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))

 

 

 


 

Item 8.01.                                        Other Events.

 

On June 2, 2016, GlaxoSmithKline plc (“GSK”) and Innoviva, Inc. (“Innoviva”) distributed a press release announcing that, following discussions with the United States Food and Drug Administration, GSK has accelerated its plan to file a New Drug Application (“NDA”) in the United States for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (“FF/UMEC/VI”), for patients with chronic obstructive pulmonary disease.  GSK now plans to file the NDA by the end of 2016, rather than the first half of 2018, as previously expected.

 

The press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1                        Press Release dated June 2, 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.

 

 

 

INNOVIVA, INC.

 

 

 

 

 

 

Date: June 2, 2016

By:

/s/ Eric d’Esparbes

 

 

Eric d’Esparbes

 

 

Chief Financial Officer

 

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