Key Developments: Onyx Pharmaceuticals Inc (ONXX.OQ)
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Latest Key Developments (Source: Significant Developments)
Pfizer Inc, Novartis AG May Join Amgen In Bidding For Onyx Pharmaceuticals Inc-Reuters
Reuters reported that Onyx Pharmaceuticals Inc whose cancer drugs promise a strong revenue stream, is attracting preliminary buyout interest from several large pharmaceutical companies such as Pfizer Inc and Novartis AG. Onyx had rejected a recent $8.7 billion offer from larger biotech Amgen Inc as too low. Pfizer, which is due to pay Onyx royalties on a promising experimental breast cancer drug, and Novartis, with a strong franchise of cancer medicines, are among the parties interested in Onyx and its portfolio of marketed cancer treatments, the two sources said. Amgen's $120-per-share offer in June was its first and the company did not indicate if it was the best and final, according to a third person familiar with the matter, who expected Amgen to participate in the auction process. The offer represented a 38% premium to Onyx's Friday closing share price of $86.82. Full Article
Onyx Pharmaceuticals Inc And Bayer HealthCare Announce Submission of FDA and EMA Applications For Nexavar (SORAFENIB) For The Treatment Of Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Onyx Pharmaceuticals Inc and Bayer HealthCare announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and an application for marketing authorization to the European Medicines Agency (EMA) for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The regulatory submission is based on data from the Phase 3 DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study. In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo. Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013. Full Article
Onyx Pharmaceuticals Inc Rejects Buyout Offer From Amgen Inc-Reuters
Reuters reported that Onyx Pharmaceuticals Inc confirmed it had rejected an offer from Amgen Inc to buy the Company for $120 a share in cash. Full Article
Onyx Pharmaceuticals Inc Confirms Receipt Of Unsolicited Acquisition Proposal From Amgen Inc
Onyx Pharmaceuticals Inc confirmed that it has received and rejected an unsolicited proposal from Amgen Inc. to acquire all of Onyx's outstanding shares and share equivalents for $120 per share in cash, subject to due diligence and other conditions. The Board of Directors of Onyx had evaluated the proposal made by Amgen with the assistance of its financial and legal advisors and concluded that the price proposed by Amgen significantly undervalued Onyx and its prospects, and was not in the best interest of Onyx or its shareholders. Onyx communicated this determination to Amgen on June 28, 2013. Based upon expressions of interest received from other third parties and the recent proposal from Amgen, the Onyx Board has authorized its financial advisor to contact potential acquirers who may have an interest in the Company in a transaction that is in the best interest of Onyx shareholders. Onyx does not intend to communicate further regarding the Amgen proposal or the process by which the Board of Directors will consider other proposals. There can be no assurance that an improved proposal will be made by Amgen or any other entity, that a definitive agreement will be executed relating to any proposed transaction, or that any transaction will be approved or consummated. Full Article
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc Announce Positive Results From Phase 3 DECISION Trial Investigating Use Of Nexavar (sorafenib) Tablets
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc announced positive results from the Phase 3 DECISION trial investigating the use of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. Sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo. The median PFS was 10.8 months among patients treated with sorafenib, compared to 5.8 months among patients receiving placebo (HR=0.587 [95% CI, 0.454-0.758]; p <0.0001). PFS was evaluated by an independent radiological review committee using Response Evaluation Criteria in Solid Tumors (RECIST). Safety and tolerability in the study were generally consistent with the known profile of sorafenib. At the time of progression, patients had the option to cross over to open-label sorafenib at the discretion of the investigator; 71% of patients in the placebo arm received open-label sorafenib after progression; 27% of patients in the sorafenib arm received open-label sorafenib after progression. There was no statistically significant difference in overall survival between the treatment arms (HR=0.802 [95% CI, 0.539-1.194]; p=0.138), a secondary endpoint of the trial. Median overall survival has not yet been reached in either arm. Full Article
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
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