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May 15, 2014
14:23 EDTNKTRNektar June volatility elevated at 127 into ASCO
Nektar June call option implied volatility is at 84, August is at 78, November is at 70; compared to its 26-week average of 70 according to Track Data, suggesting large near term price movement into ASCO's 50th annual meeting taking place May 30 through June 3.
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April 16, 2015
09:03 EDTNKTRBaxter 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 Japanís 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 7, 2015
11:10 EDTNKTRNektar management to meet with Jefferies
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