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April 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
Bristol-Myers Squibb Company announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir, a NS5A inhibitor, and asunaprevir, a NS3 inhibitor, among genotype 1b hepatitis C virus infected patients. Results showed that the 24-week regimen achieved an overall sustained virologic response 12 weeks after the end of treatment among treatment-naÔve, peginterferon/ribavirin non-responder and peginterferon/ribavirin ineligible/intolerant patients, including cirrhotic and non-cirrhotic patients. In the study the DCV+ASV regimen was generally well tolerated. These data will be presented this week at the 49th annual meeting of the European Association for the Study of the Liver The International Liver Congress in London, April 9-13. These data were part of the companyís recent DCV and ASV new drug application submissions to the U.S. Food and Drug Administration, and helped support the validated marketing authorization application to the European Medicines Agency for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. These data are comparable to a similar Phase III study of this regimen in Japanese patients, which led to the submission of a New Drug Application with Japanís Pharmaceutical and Medical Devices Agency.
News For BMY From The Last 14 Days
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October 30, 2014
15:02 EDTBMYLeerink medical devices analyst holds an analyst/industry conference call
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13:02 EDTBMYBristol-Myers, Lonza expand manufacturing agreement
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12:59 EDTBMYOn The Fly: Midday Wrap
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10:49 EDTBMYBristol-Myers rallies after CheckMate -063 Opdivo study results
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09:04 EDTBMYBristol-Myers announces CheckMate -063 Opdivo study results
Bristol-Myers Squibb announced results from CheckMate -063, a Phase 2 single-arm, open-label study of Opdivo With approximately 11 months of minimum follow up, the objective response rate was 15% as assessed by an independent review committee using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% and median overall survival was 8.2 months.These data will be presented during the Plenary Session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology on October 31. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.
07:15 EDTBMYASCO / ASTRO / IASLC to hold symposium
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05:49 EDTBMYStocks with implied volatility movement; ARCP BMY
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October 28, 2014
07:04 EDTBMYBristol-Myers enters agreement to acquire F-star Alpha, rights to FS102
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07:03 EDTBMYBristol-Myers enters agreement to acquire F-star Alpha, rights to FS102
October 27, 2014
20:54 EDTBMYLeerink's major pharma analyst holds an analyst/industry conference call
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October 24, 2014
16:02 EDTBMYOptions Update; October 24, 2014
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11:15 EDTBMYBristol-Myers says has capacity for large deal
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10:42 EDTBMYBristol-Myers sees coming in closer to high end of FY14 EPS guidance
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10:10 EDTBMYBristol-Myers to host conference call
Conference call to review data presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology (CMSTO) will be held on October 31 at 2:30 pm. Webcast Link
07:35 EDTBMYBristol-Myers reports Q3 Eliquis revenue $216M
Reports Q3 Baraclude revenue $325M, Sprycel revenue $385M, Yervoy revenue $350M. Reports Q3 Abilify revenue $449M, Orencia revenue $444M.
07:33 EDTBMYBristol-Myers confirms FY14 adjusted EPS view $1.70-$1.80, consensus $1.78
Cuts FY14 GAAP EPS view to $1.15-$1.25 from $1.50-$1.60. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2014. Sees FY14 worldwide revenue $15.2B-$15.8B, consensus $15.58B. Also sees: Full-year gross margin as a percentage of revenues between 75% and 76%. Advertising and promotion expense decreasing in the mid-teen-digit range. Marketing, sales and administrative expenses decreasing in the mid-single-digit range. Research and development expenses growing in the mid-single-digit range. An effective tax rate of 19% - 20%.
07:31 EDTBMYBristol-Myers reports Q3 adjusted EPS 45c, consensus 42c
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October 23, 2014
15:39 EDTBMYNotable companies reporting before tomorrow's open
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October 21, 2014
07:15 EDTBMYFDA to hold workshop on breast cancer drug development
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October 20, 2014
07:19 EDTBMYIBC Life Sciences to hold a conference
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