Key Developments: Baxter International Inc (BAX.N)

BAX.N on New York Stock Exchange

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17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Baxter International Inc gives Q2 2014 revenue outlook above analysts' estimates, Q2 2014 EPS outlook below analysts' estimates; reaffirms FY 2014 outlook
Thursday, 17 Apr 2014 07:00am EDT 

Baxter International Inc:Expects Q2 2014 sales growth of about 12 to 13 percent, excluding the impact of foreign currency.Expects Q2 2014 earnings, before special items, of $1.18 to $1.22 per diluted share.Q2 2014 earnings guidance excludes about $0.07 per diluted share of projected intangible asset amortization expense.The company reported revenue of $3.95 bln in Q1 2014.Q2 2014 revenues of $4.17 bln and EPS of $1.33 - Thomson Reuters I/B/E/S.Expects FY 2014 sales growth of 9 to 10 percent, before the impact of foreign exchange.FY 2014 earnings, before special items, of $5.05 to $5.25 per diluted share.FY 2014 earnings guidance excludes $0.38 per diluted share of special items comprising $0.18 per diluted share of items recorded in the Q1, and projected intangible asset amortization expense of $0.20 per diluted share for the remainder of the year.FY 2014 revenues of $16.60 bln and EPS of $5.13 - Thomson Reuters I/B/E/S.  Full Article

Baxter International invests to construct facility of $1 billion
Thursday, 17 Apr 2014 06:15am EDT 

Baxter International Inc:Decides to invest $1bln to construct a 1 mln-square-foot plasma fractionation facility with purification and fill/finish suites in Covington, Georgia.In support of the massive project, now under construction, the state is building the $14 mln Georgia BioScience Training Center adjacent to the new plant.  Full Article

Baxter International Inc meets primary efficacy endpoint in phase 3 trial of BAX 111, investigational stand-alone recombinant treatment for von willebrand disease
Wednesday, 16 Apr 2014 08:48am EDT 

Baxter International Inc:Announces topline results from a phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111.BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder.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 (HRQoL).  Full Article

Baxter International Inc to acquire Chatham Therapeutics
Wednesday, 2 Apr 2014 09:00am EDT 

Baxter International Inc:Agreed to acquire all Chatham's outstanding membership interests.Baxter will acquire Chatham's developmental gene therapy programs directed toward development and commercialization of treatments for hemophilia.  Full Article

Baxter International Inc declares quarterly dividend
Tuesday, 18 Feb 2014 09:00am EST 

Baxter International Inc:Declared a quarterly dividend of $0.49 per Baxter common share.Dividend is payable on Apr. 1, 2014 to shareholders of record as of Mar. 7, 2014.  Full Article

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

U.S. FDA approves Biogen's hemophilia B drug Alprolix

- Biogen Idec Inc has won U.S. approval for its long-acting hemophilia B treatment Alprolix, the U.S. Food and Drug Administration said on Friday.

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