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): September 2, 2015
TESARO, Inc.
(Exact name of registrant as specified in its charter)
Delaware | | 001-35587 | | 27-2249687 |
(state or other jurisdiction of
incorporation) | | (Commission
File Number) | | (I.R.S. Employer
Identification No.) |
1000 Winter Street
Suite 3300
Waltham, Massachusetts | | 02451 | | (339) 970-0900 |
(Address of principal executive offices) | | (Zip Code) | | (Registrant’s telephone number,
including area code) |
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 7.01 Regulation FD Disclosure.
On September 2, 2015, TESARO, Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration’s (FDA) approval of VARUBI™ (rolapitant). The press release announcing the approval is furnished as Exhibit 99.1 to this Form 8-K.
Item 8.01 Other Events.
On September 2, 2015, the Company announced that the FDA has approved VARUBI™ (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | | Description |
| | |
99.1 | | Press Release of the Company dated September 2, 2015 announcing FDA approval of VARUBI™. |
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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 hereunto duly authorized.
| TESARO, Inc. |
| |
| |
| By: | /s/ Joseph L. Farmer |
| | Joseph L. Farmer |
| | Senior Vice President, General Counsel and Secretary |
| |
| |
Dated: September 3, 2015 | |
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EXHIBIT INDEX
Exhibit No. | | Description |
| | |
99.1 | | Press Release of the Company dated September 2, 2015 announcing FDA approval of VARUBI™. |
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