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April 16, 2014
08:48 EDTBAXBaxter says meets primary endpoint in Phase 3 BAX 111 trial
Baxter International announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics of BAX 111. BAX 111 is a recombinant von Willebrand factor under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder. The study of BAX 111, the first recombinant treatment in clinical development for this condition, met its primary efficacy endpoint, as all patients achieved pre-specified success in the on-demand treatment of bleeding events. The Phase 3 multicenter, open-label clinical trial assessed the safety, efficacy and pharmacokinetics of BAX 111 administered together with ADVATE or as a stand-alone therapeutic agent in the on-demand treatment of 37 patients with severe von Willebrand disease at trial sites in the United States, Europe, Australia, Japan, Russia and India. The primary endpoint was the number of patients experiencing successful treatment for bleeding episodes. Secondary endpoints included additional efficacy and safety measures, pharmacokinetics and health-related quality of life. There were no reports of inhibitor development or thrombotic events in the study participants. The most common adverse events in the study were headache, vomiting/nausea and anemia (iron deficiency anemia), which were not considered to be related to treatment. There was one serious adverse event related to treatment, characterized by chest discomfort and increased heart rate during infusion, which rapidly resolved without further complication. The investigational treatment was developed using a plasma- and albumin-free manufacturing method.
News For BAX From The Last 14 Days
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July 17, 2014
09:15 EDTBAXBaxter says 'feels good' about guidance
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08:56 EDTBAXBaxter: Guidance contemplates possible headwinds related to cyclo competition
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07:05 EDTBAXBaxter sees Q3 EPS before special items $1.28-$1.32, consensus $1.32
The company said, "For Q3, the company expects sales growth of approximately 12%-13%, excluding the impact of foreign currency. TheQ3 earnings guidance excludes approximately 7c per diluted share of projected intangible asset amortization expense."
07:04 EDTBAXBaxter narrows FY14 adjusted EPS view to $5.10-$5.20, consensus $5.15
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07:02 EDTBAXBaxter reports Q2 adjusted EPS $1.26, consensus $1.22
Reports Q2 revenue $4.26B, consensus $4.12B.
07:01 EDTBAXBaxter confirms FY14 outlook
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July 16, 2014
15:27 EDTBAXNotable companies reporting before tomorrow's open
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