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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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November 24, 2015
07:01 EDTBMYBristol-Myers announces EC approved reconciliation of indications for nivolumab
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06:58 EDTBMYBristol-Myers announces FDA approval of Opdivo injection
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November 23, 2015
19:29 EDTBMYBristol-Myers receives FDA approval for Opdivo
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15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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November 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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08:11 EDTBMYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 11, 2015
05:40 EDTBMYFive Prime receives HSR clearance for collaboration agreement with Bristol-Myers
Five Prime (FPRX) announced that the FTC has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 in connection with the exclusive worldwide license and collaboration agreement with Bristol-Myers (BMY) for the development and commercialization of Five Prime's colony stimulating factor 1 receptor antibody program, including FPA008. With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with BMS is effective as of November 10, 2015, and the related $350M upfront payment by BMS to Five Prime is due within 30 days of the effective date.

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