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August 21, 2014
15:37 EDTBAX, NKTRNektar: Baxter announces positive results from Phase 3 study of BAX 855
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
News For NKTR;BAX From The Last 14 Days
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February 10, 2016
08:24 EDTNKTREnzon says Nektar granted motion to dismiss breach of contract complaint
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07:15 EDTBAXLeerink to hold a conference
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February 2, 2016
09:24 EDTBAXBaxter: 1Q16 should be weakest quarter of FY16
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08:53 EDTBAXBaxter sees FY16 CapEx $900M
Says does not anticipate any sales in 2016 in IPS. Sees FY16 surgical franchise sales growth 2%-3%. Sees FY16 renal business sales growth roughly 3%. Sees FY16 operating margin roughly 11%. Sees FY16 interest expense roughly $90M. Sees FY16 adjusted tax rate 19%-20%. Sees FY16 average share count roughly 540M shares. Sees FY16 CapEx $900M. Sees FY16 free cash flow $500M. Sees FY16 operating cash flow roughly $1.4B. Guidance taken from Q4 earnings conference call.
07:04 EDTBAXBaxter sees FY16 EPS ex-items $1.46-$1.54, consensus $1.42
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07:03 EDTBAXBaxter sees Q1 EPS ex-items 28c-30c, consensus 32c
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07:02 EDTBAXBaxter reports Q4 adjusted EPS 43c, consensus 32c
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February 1, 2016
14:32 EDTBAXNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include Exxon Mobil (XOM), consensus 64c... Pfizer (PFE), consensus 52c... United Parcel Service (UPS), consensus $1.42... Dow Chemical (DOW), consensus 70c... Emerson Electric (EMR), consensus 51c... Archer-Daniels-Midland (ADM), consensus 66c... Baxter (BAX), consensus 32c... Sirius XM (SIRI), consensus 3c... Royal Caribbean Cruises (RCL), consensus 92c... Ally Financial (ALLY), consensus 51c... Michael Kors (KORS), consensus $1.46... ADT Corp. (ADT), consensus 46c.
09:02 EDTNKTRNektar announces publication of findings for NKTR-214
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08:09 EDTBAXOptions expected to be active
Options expected to be active: GOOGL GOOG YHOO UPS KORS UPS BAX RCL CCL PFE AET D STR DWA CMG ABT SYK.
January 29, 2016
12:25 EDTBAXBaxter volatility elevated into Q4 and outlook
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