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News Breaks
August 21, 2014
09:02 EDTBAXBaxter announces BAX 855 met primary endpoint in Phase 3 study
Baxter announced "positive" results from its Phase 3 pivotal clinical trial of BAX 855, 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% reduction in median ABR as compared to those in the on-demand arm. BAX 855 was also effective in treating bleeding episodes, 96% 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 BAX From The Last 14 Days
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October 20, 2014
09:04 EDTBAXBaxter, Halozyme launch HYQVIA in U.S.
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October 16, 2014
09:04 EDTBAXBaxter says spin-off of BioScience division on track for mid-2015 completion
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09:02 EDTBAXBaxter says it still has not experienced competition for cyclophosphamide
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08:38 EDTBAXBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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07:03 EDTBAXBaxter sees FY14 continuing ops EPS $4.86-$4.89, consensus $5.16
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07:02 EDTBAXBaxter sees Q4 continuing ops EPS $1.30-$1.33, consensus $1.41
Sees Q4 sales growth approx. 3% excluding the impact of foreign currency. Including the impact of foreign currency, the company expects reported sales to be flat to 2013 levels. Consensus is $4.39B.
07:01 EDTBAXBaxter reports Q3 adjusted EPS $1.35, consensus $1.31
Reports Q3 revenue $4.2B, consensus $4.2B.
October 15, 2014
15:28 EDTBAXNotable companies reporting before tomorrow's open
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October 14, 2014
07:15 EDTBAXBaxter October volatility elevated into Q3 and guidance
Baxter October option implied volatility is at 33, November is at 23, December is at 19, February is at of 17; compared to its 26-week average of 18 according to Track Data, suggesting large near term price movement into the expected release of Q3 results on October 16.
October 13, 2014
07:37 EDTBAXAmerican Society of Anesthesiologists to hold annual meeting
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07:25 EDTBAXEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
October 10, 2014
09:54 EDTBAXJPMorgan medical supplies analyst holds an analyst/industry conference call
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October 6, 2014
07:12 EDTBAXThe MedTech Conference holds a conference
AdvaMed 2014 is being held in Chicago on October 6-8.

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