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May 28, 2014
07:59 EDTNKTRNektar June volatility elevated into ASCO
Nektar June call option implied volatility is at 91, July is at 83, August is at 78, November is at 77; compared to its 26-week average of 71 according to Track Data, suggesting large near term price movement into ASCO's 50th annual meeting taking place May 30 through June 3.
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August 21, 2014
15:37 EDTNKTRNektar: 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

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