TESARO,Inc. (NASDAQ:TSRO) Files An 8-K Other Events

ME Staff 8-k
-
0

TESARO,Inc. (NASDAQ:TSRO) Files An 8-K Other Events
Item 8.01. Other Events.

On September15, 2017, TESARO,Inc. (the “Company”) issued a press release announcing that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for the Company’s marketing authorization application (“MAA”) for ZEJULA® (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response or partial response to platinum-based chemotherapy. This opinion will now be referred to the European Commission for a final decision on the MAA.

A copy of the press release is furnished as Exhibit99.1 to this Current Report on Form8-K.

Section9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits


TESARO, Inc. Exhibit
EX-99.1 2 a17-22157_1ex99d1.htm EX-99.1 Exhibit 99.1   TESARO RECEIVES POSITIVE CHMP OPINION FOR ZEJULA®   ZUG,…
To view the full exhibit click here

About TESARO,Inc. (NASDAQ:TSRO)

TESARO, Inc. is an oncology-focused biopharmaceutical company. The Company acquires, in-licenses and develops oncology product candidates. It operates in business of developing and commercializing oncology-focused therapeutics segment. It has in-licensed and are developing oncology-related product candidates, including intravenous (IV) rolapitant and niraparib, as well as product candidates under its immuno-oncology platform. It offers VARUBI (rolapitant), which is an oral substance P/neurokinin 1 (NK-1) receptor antagonist for use 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. It is developing IV formulation of rolapitant, which has completed various Phase 1 clinical trials. Its niraparib is an orally active and poly (ADP-ribose) polymerase (PARP) inhibitor. Its immuno-oncology platform has immuno-oncology programs, which include TSR-022 and TSR-042.