Key Developments: Baxter International Inc (BAX)

BAX on New York Consolidated

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23 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Xenetic Biosciences Inc announces restructured licensing agreement with Baxter International Inc
Thursday, 30 Jan 2014 07:01am EST 

Xenetic Biosciences Inc:Receives a direct investment of $10 million from Baxter International Inc.Agrees to a restructuring of certain financial and timing aspects of its existing licensing deal with Baxter.Says amended license agreement includes increased contingent payments, totaling up to $100 million, as well as increased royalties on sales.  Full Article

Baxter International Inc issues FY, Q1 2014 guidance
Thursday, 23 Jan 2014 07:00am EST 

Baxter International Inc:Expects FY 2014 sales growth of 9 pct to 10 pct.Expects FY 2014 earnings, before special items, of $5.05 to $5.25 per diluted share(EPS).Expects Q1 2014 sales growth of about 13 pct to 14 pct.Expects Q1 2014 earnings, before special items, of $1.06 to $1.09 per diluted share (or GAAP earnings of $1.00 to $1.03 per diluted share including about $0.06 per diluted share of intangible asset amortization expense).Says it reported FY 2013 revenue of $15.3 bln.FY 2014 revenue of $16.69 bln - Thomson Reuters I/B/E/S.Q1 2014 revenue of $3.978 bln - Thomson Reuters I/B/E/S.  Full Article

Baxter International Inc receives FDA approval for FEIBA
Thursday, 19 Dec 2013 09:00am EST 

Baxter International Inc:Says that the United States Food and Drug Administration (FDA) granted approval for FEIBA [Anti-Inhibitor Coagulant Complex].Says the approval is based on data from a pivotal Phase III study, known as FEIBA PROOF, in which treatment with a FEIBA prophylactic regimen showed a 72 pct reduction in median annual bleed rate (ABR) compared to treatment with an on-demand regimen.Says in the intent-to-treat (ITT) analysis, three of the 17 (18%) adult patients in the prophylactic arm reported no bleeding episodes.Says most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.Says serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.  Full Article

Baxter International Inc submits application for FDA approval of OBI-1 for patients with acquired Hemophilia A
Tuesday, 10 Dec 2013 09:30am EST 

Baxter International Inc:Says it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.Says phase 2/3 data supporting the submission were presented at the American Society of Hematology's (ASH) 55th Annual Meeting in New Orleans, LA.  Full Article

Baxter International Inc files for pediatric indication of RIXUBIS
Monday, 9 Dec 2013 09:00am EST 

Baxter International Inc:Says it has submitted an application to the United States Food and Drug Administration (FDA) for it has submitted an application to the United States Food and Drug Administration (FDA) for a pediatric indication for RIXUBIS [Coagulation Factor IX (Recombinant)] to treat hemophilia B.Says submission was based on the results of a study presented during the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.Says RIXUBIS was approved in the United States for adults with hemophilia B earlier this year and the company filed for marketing approval in Europe in Nov. a pediatric indication for RIXUBIS [Coagulation Factor IX (Recombinant)] to treat hemophilia B.  Full Article

Baxter International Inc and Halozyme Therapeutics Inc submit amended BLA to U.S. FDA for hyqvia for primary immunodeficiency
Monday, 2 Dec 2013 09:00am EST 

Baxter International Inc and Halozyme Therapeutics Inc:Completed submission of an amended biologics license application (BLA) to the United States Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency.  Full Article

Baxter International Inc And Cell Therapeutics Inc Announce Worldwide Strategic Collaboration To Develop And Commercialize Pacritinib
Friday, 15 Nov 2013 07:30am EST 

Baxter International Inc and Cell Therapeutics, Inc jointly announced that they have entered into an exclusive worldwide licensing agreement to develop and commercialize pacritinib. Pacritinib is a investigational JAK2/FLT3 inhibitor with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. Pacritinib is currently in Phase III development for patients with myelofibrosis, a chronic malignant bone marrow disorder. Under the terms of the agreement, Baxter gains exclusive commercialization rights for all indications for pacritinib outside the United States and Baxter and CTI will jointly commercialize pacritinib in the United States. Baxter will make an upfront payment of $60 million, which includes an equity investment in CTI of $30 million. In addition, CTI is eligible to receive clinical, regulatory, and commercial launch payments of up to $112 million, $40 million of which relates to clinical milestones that may be achieved in 2014. Assuming regulatory approval and commercial launch, CTI may receive additional sales payments. CTI will receive royalties on net sales of pacritinib in ex-US markets, and the companies will share U.S. profits equally. Baxter will record a special pre-tax in-process research and development charge in the fourth quarter of 2013 of approximately $30 million.  Full Article

Baxter International Inc Declares Quarterly Dividend
Tuesday, 12 Nov 2013 09:20am EST 

Baxter International Inc announced that it has declared a quarterly dividend of $0.49 per Baxter common share. The dividend is payable on January 3, 2014 to shareholders of record as of December 6, 2013.  Full Article

Baxter International Inc Comments On Q4 2013 Revenue Guidance; Issues Q4 2013 EPS Guidance In Line With Analysts' Estimates; Updates FY 2013 Guidance
Thursday, 17 Oct 2013 07:00am EDT 

Baxter International Inc announced that for fourth quarter of 2013, it expects sales growth, excluding the impact of foreign currency, of approximately 14% to 15% (or approximately 12% to 13% including the impact of foreign currency). This includes Gambro revenues of approximately $400 million. The company projects earnings per diluted share in the fourth quarter of 2013 in a range $1.24-$1.26, before any special items. For fiscal 2013, it expects sales growth, excluding the impact of currency, of approximately 7% (or approximately 6% including the impact of foreign currency). Excluding the impact of foreign currency and the Gambro acquisition, Baxter continues to expect sales growth of approximately 4% (or approximately 3% including the impact of foreign currency). The company expects to generate revenues associated with the Gambro acquisition of approximately $500 million for the fiscal 2013. In addition, the company expects earnings of $4.65 to $4.67 per diluted share, before any special items, and cash flows from operations of approximately $3.3 billion. The company's guidance for the quarter and the full-year includes the impact of the Gambro acquisition. The Company reported revenues of $14.190 billion in fiscal 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $4.30 billion and EPS of $1.26 for fourth quarter of 2013; revenue of $15.24 billion and EPS of $4.67 for fiscal 2013.  Full Article

U.S. FDA Approves Baxter International Inc's Intravenous Nutritional Supplement-Reuters
Friday, 4 Oct 2013 12:04pm EDT 

Reuters reported that the U.S. Food and Drug Administration said on October 04, 2013 it has approved Baxter International Inc's nutritional supplement Clinolipid, moving quickly to alleviate a drug shortage. Clinolipid is an injectable source of calories and essential fatty acids designed for adults who cannot eat or drink. It contains a mixture of refined olive and soybean oils. Clinolipid was compared in tests with soybean oil-based lipid emulsions. The agency said the omega-3 to omega-6 fatty acid ratio in Clinolipid has not been shown to improve patient outcomes more than other lipid emulsions. The most common side effects of Clinolipid include nausea and vomiting, excess fat in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests. The product is not approved for use in children.  Full Article

Gambro acquisition boosts Baxter's sales

- Medical device and drug maker Baxter International Inc reported higher-than-expected quarterly adjusted earnings, driven primarily by a surge in sales of the dialysis products it gained from its acquisition of Gambro AB [EQTPRM.UL] last year.

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