Key Developments: Onyx Pharmaceuticals Inc (ONXX.O)
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22 May 2013
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Latest Key Developments (Source: Significant Developments)
Onyx Pharmaceuticals Inc's Stivarga (regorafenib) Tablets Approved By U.S. FDA For Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic GIST
Onyx Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.1 Stivarga was approved by the FDA in September 2012 for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.1 Full Article
Onyx Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Onyx Pharmaceuticals Inc announced the pricing of an underwritten public offering of 4,400,000 shares of common stock. The gross proceeds to Onyx from this offering are expected to be approximately $358,600,000, before underwriting discounts and commissions and other estimated offering expenses payable by Onyx. Onyx has also granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock offered in the public offering to cover overallotments, if any. The offering is expected to close on or about January 22, 2013. Onyx intends to use the net proceeds from this offering to fund clinical development programs, research and development activities, and sales and marketing activities to commercialize Kyprolis around the world, and for general corporate purposes, including working capital. BofA Merrill Lynch and Barclays are acting as joint book-running managers for this offering. Full Article
Onyx Pharmaceuticals Inc Announces Public Offering Of Common Stock
Onyx Pharmaceuticals Inc announced that an underwritten public offering of 4,400,000 shares of its common stock. Onyx has also granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock offered in the public offering to cover overallotments, if any. The offering is expected to close on or about January 22, 2013, subject to customary closing conditions. Onyx intends to use the net proceeds from this offering to fund its clinical development programs, research and development activities, and sales and marketing activities to commercialize Kyprolis around the world, and for general corporate purposes, including working capital. BofA Merrill Lynch and Barclays are acting as joint book-running managers for this offering. Full Article
Bayer AG's Bayer HealthCare Pharmaceuticals And Onyx Pharmaceuticals, Inc.'s Phase 3 DECISION Trial Of Nexavar (sorafenib) Meets Primary Endpoint
Bayer AG's Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met primary endpoint of a statistically improvement of progression-free survival. The study, called DECISION, evaluated efficacy and safety of Nexavar compared to placebo. Adverse events were generally consistent with the known profile for Nexavar. The companies anticipate that this data will form basis for regulatory submission of Nexavar in treatment of RAI-refractory differentiated thyroid cancer. The DECISION (study of sorafenib in locally advanced or metastatic patients with radioactive Iodine refractory thyroid cancer) trial was an international, multicenter, randomized, placebo-controlled study that randomized 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer. The primary endpoint of study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors. Secondary endpoints included overall survival, time to progression, response rate and duration of response. Full Article
Onyx Pharmaceuticals Inc Announces N. Anthony Coles, M.D. as Chairman of Board of Directors
Onyx Pharmaceuticals Inc announced that its Board of Directors has elected N. Anthony Coles, M.D., Chairman of the Board. Dr. Coles is currently President, Chief Executive Officer and a member of Onyx's Board. Paul Goddard, Ph.D., will continue to serve as Lead Independent Director of the Onyx Board. Full Article
Onyx Pharmaceuticals Inc Submits New Drug Application For Regorafenib For Treatment Of Gastrointestinal Stromal Tumors
Onyx Pharmaceuticals Inc announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment. Full Article
Onyx Pharmaceuticals, Inc., Bayer AG's HealthCare Pharmaceuticals And Astellas Pharma Inc Announce Tarceva To Nexavar Did Not Provide Additional Benefit To Patients
Onyx Pharmaceuticals, Inc., Bayer AG's HealthCare Pharmaceuticals and Astellas Pharma Inc announced that a Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone. The SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial compared Nexavar in combination with Tarceva to Nexavar alone. The safety and tolerability of the treatment combination were generally as expected based upon experience and use of the two products alone and there were no new or unexpected toxicities or changes to the respective product safety profiles observed. Nexavar is jointly developed by Bayer and Onyx. Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Group. The SEARCH trial was an international multicenter placebo-controlled Phase III study that randomized 720 patients with advanced liver cancer. The study examined whether the addition of Tarceva to Nexavar prolongs survival as compared to Nexavar alone in patients with unresectable HCC. The primary endpoint of the study was overall survival (OS) and the secondary endpoints were safety, time to radiographic progression (TTP), disease control rate (DCR) and patient-reported outcome. Full Article
Onyx Pharmaceuticals, Inc. Receives FDA Accelerated Approval Of Kyprolis For Injection
Onyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Kyprolis (carfilzomib) for Injection, a proteasome inhibitor, indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. The indication for Kyprolis is based on response rate. Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival. The approval was based on the results of the Phase 2b 003-A1 study, a single-arm, multicenter clinical trial that enrolled 266 patients with multiple myeloma who had received a median of five prior anti-myeloma regimens. The primary efficacy endpoint was overall response (ORR) and determined by an Independent Review Committee using the International Myeloma Working Group (IMWG) criteria. ORR was 22.9% and median response duration was 7.8 months. Full Article
U.S. FDA Grants Priority Review To New Drug Application For Bayer AG's Bayer HealthCare And Onyx Pharmaceuticals' Regorafenib To Treat Patients With Metastatic Colorectal Cancer
Bayer AG's Bayer HealthCare and Onyx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies. The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle. The submission was based upon data from the pivotal, global Phase III CORRECT study. Full Article
US FDA Advisers Back Onyx Pharmaceuticals Blood Cancer Drug-Reuters
Reuters reported that U.S. drug advisers backed Onyx Pharmaceuticals’s drug for patients who have failed to successfully treat their blood cancer with other medicines, making it likely the drug would secure approval from U.S. regulators. A panel of outside advisers to the Food and Drug Administration voted unanimously to recommend approval of Onyx’s drug, to be sold as Kyprolis, for treating multiple myeloma in people who have tried at least two other medicines. Full Article
FUNDVIEW-Healthcare M&A to gain pace in 2013 - OrbiMed's Isaly
Feb 7 - Healthcare deals will rebound this year after a weak 2012, with providers of innovative technologies, cancer treatments and diagnostics being the most likely targets, the founder and managing partner of healthcare-focused OrbiMed Advisors said.
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