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News Breaks
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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April 23, 2015
08:57 EDTBAXBaxter still sees separation costs just above $300M, or 2% of sales
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08:41 EDTBAXBaxter says separation of two companies on track for mid-2015
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07:21 EDTBAXBaxter sees Q2 continuing ops EPS 92c-96c, consensus $1.01
The company expects sales growth of approximately 1%, excluding the impact of foreign currency. Including the impact of foreign currency, the company expects sales to decline approximately 9%-10%. Consensus is $3.92B. Baxter also expects earnings from continuing operations, before special items, of 92c-96c per diluted share. The Q2 earnings guidance excludes approximately 8c per diluted share of projected intangible amortization expense. Reconciling for the inclusion of intangible asset amortization results in expected GAAP earnings of 84c-88c per diluted share, before other special items, for the quarter.
07:01 EDTBAXBaxter reports Q1 adjusted EPS $1.00, consensus 88c
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April 22, 2015
15:50 EDTBAXNotable companies reporting before tomorrow's open
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08:49 EDTBAXCTI BioPharma, Baxter to announce Phase 3 pacritinib data at ASCO late-breaker
CTI BioPharma (CTIC) and Baxter (BAX) announced that data from the randomized Phase 3 PERSIST-1 trial evaluating the investigational agent pacritinib in patients with myelofibrosis will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology, or ASCO, meeting, to be held May 29-June 2 in Chicago. These data have also been selected as part of this year's official ASCO press briefing – titled "Targeted Therapy" – to be held on Saturday, May 30, at 8:00 am CT, the companies said.
April 21, 2015
09:09 EDTBAXJPMorgan medical tech & devices analyst holds analyst/industry conference call
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April 17, 2015
16:36 EDTBAXBaxter says results of Phase III clinical trial of BAX 111 met primary endpoint
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April 16, 2015
09:03 EDTBAXBaxter submits application to Japan's MHLW for approval of BAX 855
Baxter International (BAX) announced that the company has submitted a new drug application to Japan’s Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII treatment based on ADVATE for patients over 12 years of age with hemophilia A. The submission follows the filing to the United States Food and Drug Administration in late 2014 and is based on positive results from a prospective, global, Phase 3 study of 137 previously treated patients. The results, presented during the European Association for Haemophilia and Allied Disorders meeting in February 2015, demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older. Baxter continues to advance a continuation study for patients who completed the pivotal trial and a Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A. Once the pediatric study has been completed, the company expects to file for marketing authorization with the European Medicines Agency in 2016 and intends to seek post-approval label expansion in the U.S. for previously-untreated pediatric patients. BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 12 years of real-world experience. Through a collaboration with Nektar Therapeutics (NKTR), BAX 855 leverages proprietary pegylation technology designed to extend the duration of activity of the protein in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions.
April 15, 2015
08:13 EDTBAXCoherus, Baxter announce amendment to etanercept biosimilar agreement
Coherus BioSciences (CHRS) and Baxter International (BAX) announced that they have amended certain financial terms of their collaboration agreement established in August 2013 regarding the development and commercialization of CHS-0214, an etanercept biosimilar product candidate, for Europe, Canada, Brazil, and certain other markets. Under the terms of the amended agreement, certain existing milestones and funding obligations have been revised, and the collaboration has been expanded to include select pre-commercialization activities. In aggregate, the revised milestone payments may exceed the previous Baxter funding obligations by approximately $12M. Additionally, Baxter has agreed to purchase Coherus common stock in a private placement transaction. All other contractual provisions remain materially unchanged.
April 14, 2015
07:38 EDTBAXBaxter removed from the short-term buy list at Deutsche Bank
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