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TESARO Announces Fourth Quarter and Year-end 2012 Operating Results
· Niraparib to be Advanced in a Phase 3 Pivotal Trial for Ovarian Cancer
· Enrollment Continues in the Global Registration Program for Rolapitant
· Achieved Third Dose-level in a Phase 1/2 Clinical Trial of TSR-011
Waltham, Massachusetts February 14, 2013 TESARO, Inc. (Nasdaq: TSRO) an oncology-focused biopharmaceutical company today reported financial results for the fourth quarter and full year 2012 and provided an update on the Companys progress.
We are very pleased to be advancing niraparib into a registration program in the maintenance setting for platinum sensitive ovarian cancer and intend to initiate this Phase 3 clinical trial by mid-year, said Lonnie Moulder, Chief Executive Officer. In addition, we are on track to report topline results from the rolapitant global registration program in the second half of the year, and have achieved the third dose-level in a Phase 1/2 clinical trial for TSR-011. We look forward to an exciting and productive 2013 for TESARO.
TESARO continues to advance the development of its pipeline of oncology supportive care and anticancer product candidates.
· The Company has met with the FDA and finalized its clinical development program for niraparib, an orally active and potent PARP (poly (ADP-ribose) polymerase) inhibitor, in the ovarian cancer setting. TESARO will initiate a pivotal Phase 3 randomized double-blind, international trial to evaluate the potential benefit of niraparib compared to a placebo on the maintenance of response following completion of a platinum containing chemotherapy regimen. The study will separately evaluate the benefit of niraparib in two groups of ovarian cancer patients, those with and without certain deficiencies in DNA repair. The rationale for this study includes robust Phase 1 and 2 data showing a high response rate in patients with ovarian cancer who are treated with PARP inhibitors, compelling Phase 1 data from the dose escalation and expansion clinical study of niraparib, as well as the results of a study with a comparable design in the ovarian cancer maintenance setting that showed a strong progression free survival, or PFS, benefit for patients receiving another investigational PARP inhibitor. The Company expects to initiate this Phase 3 clinical trial by mid-year.
The following information was filed by Tesaro, Inc. (TSRO) on Thursday, February 14, 2013 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.
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