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8-K Filing
Innoviva (INVA) 8-KOther Events
Filed: 30 Jun 14, 12:00am
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the |
Date of Report: June 30, 2014 (Date of earliest event reported) | ||||
Theravance, Inc. (Exact name of registrant as specified in its charter) | ||||
Delaware (State or other jurisdiction of incorporation) | 000-30319 (Commission File Number) | 94-3265960 (IRS Employer Identification Number) | ||
951 Gateway Boulevard, South San Francisco, CA (Address of principal executive offices) | 94080 (Zip Code) | |||
650-238-9600 (Registrant's telephone number, including area code) | ||||
Not Applicable (Former Name or Former Address, if changed since last report) |
Item 8.01. Other Events On June 30, 2014, GlaxoSmithKline plc and Theravance, Inc. issued a press release announcing the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist (LABA), vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of BREO(R) ELLIPTA(R). The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the ELLIPTA(R) dry powder inhaler. FF/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc. A copy of 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 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. |
Dated: June 30, 2014 | THERAVANCE, INC. By: /s/ Michael W. Aguiar |
Exhibit No. | Description |
99.1 | Press Release dated June 30, 2014 |