Please wait while we load the requested 10-K report or click the link below:
TESARO ANNOUNCES FOURTH-QUARTER 2015 OPERATING RESULTS
· U.S. commercial launch of VARUBI® (oral rolapitant) well underway
· Niraparib Phase 3 NOVA results expected in Q2 2016 are positioned to be the first data from a randomized, prospective Phase 3 trial of a PARP inhibitor
· New Drug Application (NDA) submission for niraparib planned for 2H 2016
· Investigational New Drug (IND) application for TSR-042 cleared by FDA
· IND submission for TSR-022 (anti-TIM-3 antibody) planned for Q2 2016
· Cash and cash equivalents totaled $230.1 million as of December 31, 2015
· Private placement financing will add an additional $155 million upon closing
WALTHAM, Mass., Feb. 25, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for fourth-quarter 2015 and provided an update on the Companys development programs.
2016 is poised to be another exciting year for TESARO as we continue to drive awareness of CINV and work to make VARUBI® available to all eligible patients, said Lonnie Moulder, CEO of TESARO. We have implemented a comprehensive, global development program for niraparib in ovarian cancer that spans the treatment and maintenance settings, several patient subgroups and multiple lines of therapy, and we are also exploring combination and monotherapy approaches for additional tumor types. We continue to anticipate that data from our NOVA and QUADRA registration trials of niraparib will become available during the second quarter. Our NOVA study results will be the first data from a prospectively designed, randomized Phase 3 trial for a PARP inhibitor, and the full data from this global trial are intended to support regulatory applications and submissions to payors and pricing authorities as part of our commercialization strategy for the U.S. and European markets. We are enthusiastic about the potential for our pipeline candidates to create significant value for shareholders, particularly by expanding our niraparib development program into additional tumor types and advancing our portfolio of immuno-oncology candidates into the clinic.
Recent Business Highlights
· TESARO launched VARUBI® (oral rolapitant) in November of 2015, following U.S. Food and Drug Administration (FDA) approval 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, including, but not limited to, highly emetogenic chemotherapy.
· The intravenous (IV) rolapitant development program is complete, and a New Drug Application (NDA) will be submitted to the FDA in the first quarter of 2016.
· Patient treatment continues in the Phase 3 NOVA trial of niraparib in patients with ovarian cancer, and based upon the observed event rate, TESARO continues to expect data in the second quarter of 2016.
The following information was filed by Tesaro, Inc. (TSRO) on Thursday, February 25, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one year to another to evaluate Tesaro, Inc.'s financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Tesaro, Inc..