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 |
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000-30319 |
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94-3265960 |
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.