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News Breaks
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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December 22, 2014
09:03 EDTBAXBaxter submits application for FDA approval of BAX111
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December 15, 2014
09:03 EDTBAXBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
December 11, 2014
18:03 EDTNKTRNektar reports data from Phase 3 BEACON study of NKTR-102
Nektar Therapeutics presented biomarker data from a sub-study of the Phase 3 BEACON study of etirinotecan pegol (NKTR-102) which collected and analyzed circulating tumor cell samples from patients in the study. A total of 80% of the 852 patients enrolled in the BEACON trial participated in the CTC sub-study. Among the 627 patients who participated and had evaluable baseline samples, CTCs were detected in 97% of these samples. For the 611 evaluable baseline patient samples which yielded CTCs, potential NKTR-102 target-specific pharmacodynamic biomarkers were detected in the majority of samples. The pharmacodynamic biomarkers assessed in the CTC sub-study were chosen because of their potential ability to predict response to topoisomerase inhibition as well as to measure chemo-sensitivity in metastatic cancer patients
08:05 EDTNKTRFDA Pediatric Oncologic Subcommittee to hold a meeting
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December 10, 2014
17:19 EDTBAXBaxter announces filing of Form 10 in connection with planned spin-off
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December 9, 2014
12:22 EDTBAXPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
08:02 EDTNKTRMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTNKTRAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
07:29 EDTNKTRUBS to hold investor trip
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07:18 EDTNKTRUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.

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