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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.
News For BMY From The Last 14 Days
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July 25, 2014
07:27 EDTBMYEMA recommends expanded indication for Baraclude
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06:00 EDTBMYBristol-Myers implied volatility of 17 at lower end of index mean range
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July 24, 2014
11:22 EDTBMYBristol-Myers says considering different sizes of deal opportunities
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10:57 EDTBMYBristol-Myers says M&A would have to be good strategic fit
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10:48 EDTBMYBristol-Myers says guidance assumes R&D credit will be extended
Says Reyataz seeing increased competitive pressure. Says business development a top priority for capital allocation. Comments made on the Q2 earnings conference call.
08:28 EDTBMYBristol-Myers management to meet with JPMorgan
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07:32 EDTBMYBristol-Myers reaffirms 2014 EPS outlook $1.70-$1.80, consensus $1.77
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07:31 EDTBMYBristol-Myers reports Q2 EPS 48c, consensus 44c
Reports Q2 revenue $ $3.89B, consensus $3.85B.
05:26 EDTBMYBristol-Myers, Ono Pharmaceutical announces strategic collaboration in Japan
Bristol-Myers Squibb and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo and Yervoy across a broad range of tumor types. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.
July 23, 2014
15:30 EDTBMYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Ford (F), consensus 36c; General Motors (GM), consensus 58c; Potash (POT), consensus 46c; Caterpillar (CAT), consensus $1.52; 3M (MMM), consensus $1.91; Union Pacific (UNP), consensus $1.43; Bristol-Myers Squibb (BMY), consensus 44c; Eli Lilly (LLY), consensus 65c; Celgene (CELG), consensus 89c; Precision Castparts (PCP), consensus $3.35; Raytheon (RTN), consensus $1.59; Noble Energy (NBL), consensus 79c; Hershey (HSY), consensus 76c; Southwest Airlines (LUV), consensus 61c; Boston Scientific (BSX), consensus 19c; JetBlue (JBLU), consensus 19c.
15:10 EDTBMYBristol-Myers technical comments before earnings
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July 21, 2014
06:43 EDTBMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 17, 2014
08:08 EDTBMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
06:26 EDTBMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTBMYPerrigo retreats after analyst sees limited potential buyers
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07:35 EDTBMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.

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