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FOR RELEASE ON FEBRUARY 19, 2014 at 4:01 PM ET
TESARO ANNOUNCES FOURTH-QUARTER AND FULL-YEAR 2013
· Oral Rolapitant New Drug Application on Track for Submission to U.S. FDA in Mid-2014
· Niraparib Phase 3 NOVA and BRAVO Trials Continue to Advance
· Cash and Cash Equivalents Totaled Approximately $130 Million as of December 31, 2013
· Successful Follow-On Offering Raised Approximately $94 Million in February 2014
WALTHAM, MA, February 19, 2014 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported financial results for fourth-quarter and full-year 2013.
During 2013, TESARO successfully completed two Phase 3 trials of oral rolapitant, advanced the IV formulation of rolapitant, initiated two new pivotal trials for niraparib, and presented the first clinical data for TSR-011, said Lonnie Moulder, CEO of TESARO. We intend to build on the significant progress the company has made by submitting the NDA for oral rolapitant, continuing to enroll our Phase 3 niraparib trials, and presenting data at key medical meetings in 2014. Following the recent completion of a follow-on offering of common stock, we believe we are well positioned to fund the launch of oral rolapitant, advance and expand the niraparib development program and execute on potential business development opportunities.
Recent Business Highlights
· In December, the Company announced that two Phase 3 trials of oral rolapitant, one in patients receiving moderately emetogenic chemotherapy (MEC) and one in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC), each met the primary endpoint of complete response (CR) in the delayed (24 to 120 hour) timeframe following chemotherapy.
· Enrollment of the third and final Phase 3 trial of oral rolapitant, which is being conducted in patients receiving cisplatin-based HEC, is expected to conclude during the first quarter of 2014. TESARO anticipates that results from this study will be available in the second quarter of 2014.
· The clinical trial of intravenous (IV) rolapitant is well underway, and the Company anticipates finalizing the dose that will provide comparable exposure to the oral formulation by the end of the first quarter of 2014.
· The Phase 3 NOVA study of niraparib in patients with high grade serous, platinum-sensitive ovarian cancer, including those with germline BRCA mutations, continues to enroll patients at sites around the world.
· The Company expects to initiate patient treatment during the first quarter of 2014 in the Phase 3 BRAVO study of niraparib in breast cancer patients with germline BRCA mutations.
· TESARO continues to evaluate the clinical activity of a 60 milligram fractionated dose of TSR-011 in an ongoing trial in both ALK-positive and TRK-positive patients.
The following information was filed by Tesaro, Inc. (TSRO) on Wednesday, February 19, 2014 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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