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FOR RELEASE ON FEBRUARY 28, 2017 AT 4:05 PM ET
TESARO ANNOUNCES FOURTH-QUARTER 2016 OPERATING RESULTS
· Niraparib NDA under review by FDA; pre-launch preparations for planned commercial launch well underway
· Expanded access program (EAP) for niraparib open in U.S.; European EAP expected to open 1H 2017
· Positive opinion rendered for VARUBY® by the European Medicine Agencys CHMP; European launch planned for 2Q 2017
· International headquarters and European operations established to cover 17 target countries
· Registration program for niraparib in lung cancer to be finalized in 1H 2017
· TSR-042 (anti-PD-1 antibody) registration program to initiate in 2Q 2017
· Cash and cash equivalents totaled approximately $786 million as of December 31, 2016
WALTHAM, Mass., Feb. 28, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for fourth-quarter 2016 and provided an update on the Companys development programs.
2017 is poised to be an eventful year for TESARO as we prepare for four product launches across the United States and Europe, said Lonnie Moulder, CEO of TESARO. 2016 was an important year for the Company, highlighted by the landmark NOVA trial results for niraparib, which were published in the New England Journal of Medicine and presented in a presidential session at the European Society of Medical Oncology annual meeting. We intend to build upon these successes in 2017 with the planned launch of niraparib in the U.S. during the first half of this year and in Europe by year end. Looking beyond ovarian and breast cancer, we aim to finalize and initiate our registration program for niraparib in lung cancer in the first half of this year. Lastly, we are excited about the progress in our immuno-oncology pipeline, and expect to initiate a registrational program for TSR-042 in the coming months.
Recent Business Highlights
· The U.S. launch of VARUBI® continues, with sequential unit volume growth for the fourth quarter of 2016. For the month of December, VARUBI achieved greater than 40% market share in the oral NK-1 market in the U.S., which represents the market-leading position in the category.
· The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the marketing authorization application (MAA) for VARUBY® for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
The following information was filed by Tesaro, Inc. (TSRO) on Tuesday, February 28, 2017 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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