Key Developments: Bristol-Myers Squibb Co (BMYMP.PK)

BMYMP.PK on OTC Markets Group

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2 Oct 2014
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Squibb, Pharmacyclics and Janssen announce clinical collaboration to evaluate OPDIVO and IMBRUVICA (ibrutinib) in Non-Hodgkin Lymphoma
Monday, 13 Oct 2014 08:00am EDT 

Bristol-Myers Squibb Co, Pharmacyclics Inc and Janssen Research & Development, LLC:Enters into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor in combination with IMBRUVICA.Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL).Bristol-Myers Squibb has proposed the name OPDIVO which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab.Study will be conducted by Janssen.Additional details of the collaboration were not disclosed.  Full Article

Bristol-Myers Squibb announces collaboration to Evaluate Opdivo in combination with Targeted Therapies from Novartis to Treat Non-Small Cell Lung Cancer
Monday, 6 Oct 2014 08:00am EDT 

Bristol-Myers Squibb Co:Bristol-Myers Squibb announces collaboration to Evaluate Opdivo (nivolumab) in Combination with Targeted Therapies from Novartis to Treat Non-Small Cell Lung Cancer (NSCLC).Says establishment of clinical trial collaboration to evaluate safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab).Says with three molecularly targeted oncology therapies ( Zykadia (ceritinib), INC280 and EGF816) from Novartis.Novartis will conduct two Phase 1/2 studies focused on non-small cell lung cancer (NSCLC).  Full Article

European Medicines Agency validates the marketing authorization application for Bristol-Myers Squibb Co 's Nivolumab in non-small cell lung cancer
Monday, 29 Sep 2014 08:21am EDT 

Bristol-Myers Squibb Co:Says the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for nivolumab in non-small cell lung cancer (NSCLC) - the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type.Says MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC (Study -063).Says in addition to the MAA for lung cancer in the E.U., the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.  Full Article

Bristol-Myers Squibb Co announces positive phase 3 data for opdivo (Nivolumab) in advanced melanoma patients treated with yervoy
Monday, 29 Sep 2014 03:00am EDT 

Bristol-Myers Squibb Co:Says positive results from CheckMate -037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), versus investigator's choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab).Based on a planned interim analysis of the co-primary endpoint, the objective response rate (ORR) was 32 pct (95 pct CI = 24, 41) in the Opdivo arm (n=120) and 11 pct (95 pct CI = 4, 23) in the ICC reference arm (n=47) in patients with at least six months of follow up.Majority (95 pct) of responses were ongoing in the Opdivo arm and the median duration of response was not reached. ORR was based on RECIST criteria as evaluated by an independent radiologic review committee (IRRC).  Full Article

Bristol-Myers Squibb Co announces dividend
Tuesday, 16 Sep 2014 04:30pm EDT 

Bristol-Myers Squibb Co:Declares quarterly dividend of $0.36 per share on the $.10 par value Common Stock of the corporation.The next quarterly dividend will be payable on Nov. 03 to stockholders of record on Oct. 03.The directors also declared a quarterly dividend of $0.50 per share on the $2.00 Convertible Preferred Stock of the corporation.Payable Dec. 01 to stockholders of record on Nov. 07.  Full Article

Bristol-Myers Squibb Co reaffirms FY 2014 EPS guidance - Conference Call
Monday, 8 Sep 2014 02:00pm EDT 

Bristol-Myers Squibb Co:Confirms non-GAAP earnings forecast guidance of $1.70 to $1.80 for FY 2014.  Full Article

Bristol-Myers Squibb Company and Pfizer Inc announces results of secondary analysis of Eliquis Phase 3 AMPLIFY-EXT trial
Sunday, 31 Aug 2014 05:04am EDT 

Bristol-Myers Squibb Company and Pfizer Inc:Announces results of a pre-specified secondary analysis of the Eliquis Phase 3 AMPLIFY-EXT trial (A pixaban after the initial M anagement of P u L monary embol I sm and deep vein thrombosis with F irst-line therap Y - EXT ended Treatment).The analysis evaluated clinical and demographic predictors of all-cause hospitalization in patients with VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).Says results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo.Says this effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population.  Full Article

European Commission Approves Bristol-Myers Squibb Co' s Daklinza (daclatasvir) across multiple genotypes for treatment of Chronic Hepatitis C Infection
Wednesday, 27 Aug 2014 05:00am EDT 

Bristol-Myers Squibb Co:Announced that European Commission has approved Daklinza (daclatasvir), potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ).Daklinza use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for treatment of chronic hepatitis C virus (HCV) infection in adults.Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100 pct in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors.Daklinza is first NS5A complex inhibitor approved in European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.  Full Article

Bristol-Myers Squibb Co and Pfizer announces U.S. FDA approves Eliquis (apixaban)
Thursday, 21 Aug 2014 01:31pm EDT 

Bristol-Myers Squibb Co and Pfizer:Says U.S. Food and Drug Administration (FDA) has approves Supplemental New Drug Application (sNDA) for Eliquis for treatment of DVT and PE, and for reduction in risk of recurrent DVT and PE following initial therapy.Combined, DVT and PE are known as VTE.It is estimated that every year, about 900,000 Americans are affected by DVT and PE.  Full Article

Bristol-Myers Squibb and Celgene enter clinical collaboration agreement to evaluate immunotherapy and chemotherapy combination regimen
Wednesday, 20 Aug 2014 08:00am EDT 

Bristol-Myers Squibb Co:To establish a clinical trial collaboration with Celgene.To evaluate safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, OPDIVO, and Celgene's nab (technology-based chemotherapy ABRAXANE), in a Phase I study.Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).Proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval.Study is expected to begin in the fourth quarter of 2014 to be conducted by Celgene.  Full Article

ConvaTec owners appoint banks to explore sale: sources

LONDON - ConvaTec's owners have appointed Morgan Stanley and Goldman Sachs to explore a sale of the medical device maker which could be worth up to $10 billion, sources familiar with the matter said.

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