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News Breaks
June 24, 2014
16:47 EDTBMYBristol-Myers says Phase 3 study of nivolumab versus dacarbazine stopped early
Bristol-Myers Squibb announced that a randomized blinded comparative Phase 3 study evaluating nivolumab versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab. The company will share these data with health authorities. “The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, MD, Head of Oncology Development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival.” CheckMate -066 investigators have been informed of the decision to stop the blinded comparative portion of the trial. Bristol-Myers Squibb will ensure that patients are informed of the opportunity to continue or start treatment with nivolumab in an open-label extension as part of the company’s commitment to characterize long-term survival. The study, which was designed in consultation with the Committee for Medicinal Products for Human Use, was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, but not at U.S. trial sites. The company will complete a full evaluation of the final CheckMate -066 data and work with investigators on the future presentation and publication of the results.
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October 30, 2014
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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October 16, 2014
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
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