Key Developments: Bristol-Myers Squibb Co (BMY.N)

BMY.N on New York Stock Exchange

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26 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Squibb announces U.S. FDA approval of Opdivo (nivolumab)
Monday, 22 Dec 2014 03:11pm EST 

Bristol-Myers Squibb:Says the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab).  Full Article

ONO PHARMACEUTICAL CO LTD, Bristol-Myers Squibb and Kyowa Hakko Kirin announces Immuno-Oncology Clinical collaboration studying Opdivo (nivolumab) and Mogamulizumab in Advanced Solid Tumors
Wednesday, 10 Dec 2014 06:00am EST 

ONO PHARMACEUTICAL CO LTD, Bristol-Myers Squibb Co and Kyowa Hakko Kirin Co Ltd:Enters into a clinical trial collaboration agreement to conduct a Phase 1 combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody.Study will focus on evaluating the safety, tolerability and anti-tumor activity of combining Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.Study will be conducted by Ono and Kyowa Hakko Kirin.Additional details of the collaboration were not disclosed.  Full Article

Bristol-Myers Squibb Co announces dividend
Tuesday, 9 Dec 2014 04:30pm EST 

Bristol-Myers Squibb Co:Declares a quarterly dividend of $0.37 per share on the $.10 par value Common Stock of the corporation.Next quarterly dividend will be payable on Feb. 02, 2015, to stockholders of record on Jan. 02, 2015.Directors also declared a quarterly dividend of $0.50 per share on $2.00 Convertible Preferred Stock of the corporation.Payable March 2, 2015 to stockholders of record on Feb. 06, 2015.  Full Article

Bristol-Myers Squibb foundation awards nine grants totaling more than $3.5 mln to support care for high-risk patients with Hepatitis B and C in China and India
Wednesday, 3 Dec 2014 09:00am EST 

Bristol-Myers Squibb Co:Announces nine new grants totaling more than $3.5 mln to strengthen efforts in China and India in fight against hepatitis B virus (HBV) and hepatitis C virus (HCV) infection by focusing on most vulnerable, high-risk patient populations.The multi-year grants were made through Foundation's Delivering Hope initiative, which has supported more than 40 projects in China and India since 2002.These new grants align with World Health Organization's (WHO) strategies for reducing incidence of HBV and HCV infection through early diagnosis and screening of high-risk populations, including intravenous drug users and patients co-infected with HIV and/or tuberculosis.Several focus on increasing awareness about disease transmission among health care providers who care for HBV- and HCV-infected patients, who also are considered at-risk for contracting viral hepatitis.  Full Article

Bristol-Myers Squibb receives complete response letter from U.S. FDA for Daclatasvir
Wednesday, 26 Nov 2014 11:34am EST 

Bristol-Myers Squibb Co:Announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV).Says the initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor.  Full Article

Bristol-Myers Squibb Co and Five Prime Therapeutics announce exclusive clinical collaboration to evaluate combination of investigational immunotherapies Opdivo and FPA008 in Six Tumor Types
Monday, 24 Nov 2014 08:59am EST 

Bristol-Myers Squibb Co:Entered into an exclusive clinical collaboration agreement with Five Prime Therapeutics.To evaluate safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb's investigational PD-1 (programmed death-1) immune checkpoint inhibitor, with FPA008, Five Prime's monoclonal antibody that inhibits colony stimulating factor-1 receptor.Phase 1a/1b study will evaluate combination of Opdivo and FPA008 as potential treatment option for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.Bristol-Myers Squibb has proposed name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.  Full Article

Allied Minds Plc and Bristol-Myers Squibb Co forms strategic partnership with Synergy Partners R&D solutions
Tuesday, 18 Nov 2014 02:00am EST 

Allied Minds Plc and Bristol-Myers Squibb Co:Says that it formed a strategic partnership with Synergy Partners R&D Solutions, LLC.  Full Article

Bristol-Myers Squibb Co announces results from CheckMate -066, a Phase 3 randomized double blind study
Saturday, 15 Nov 2014 11:00pm EST 

Bristol-Myers Squibb Co:Announces results from CheckMate -066, a Phase 3 randomized double blind study, comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to the chemotherapy dacarbazine in patients with treatment naïve BRAF wild type advanced melanoma.Says the study met the primary endpoint of overall survival (OS) with the median OS not reached for Opdivo vs. 10.8 months for DTIC.Says te one year survival rate was 73 pct. for Opdivo vs. 42 pct. for DTIC and there was a 58 pct. decrease in the risk of death for patients treated with Opdivo.Says this survival advantage was also observed in Opdivo treated patients in both PD-L1 positive and PD-L1 negative patients.Says the results from CheckMate -066 are significant as they represent the first time a PD-1 immune checkpoint inhibitor has shown a survival benefit in a randomized Phase 3 trial.  Full Article

Bristol-Myers Squibb Co announces high cure rates for investigational, all-oral daclatasvir trio fixed-dose combination in genotype 1 hepatitis c patients, including those with cirrhosis
Saturday, 8 Nov 2014 09:00am EST 

Bristol-Myers Squibb Co:Announces late-breaking data from the UNITY Trial program investigating a 12-week regimen of its all-oral daclatasvir (DCV) TRIO regimen - a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) in a broad range of patients with genotype 1 hepatitis C virus.Says the the primary endpoint for both studies was the percentage of patients who achieved cure, defined as HCV RNA Full Article

Bristol-Myers Squibb Co Signs Exclusive Option Agreement to acquire Galecto Biotech AB and Novel Galectin-3 Inhibitor in Development for Idiopathic Pulmonary Fibrosis
Monday, 3 Nov 2014 08:30am EST 

Bristol-Myers Squibb Co:Entered into an agreement that provides exclusive option to acquire Galecto Biotech AB and gain worldwide rights to its lead asset TD139, novel inhaled inhibitor of galectin-3 in Phase 1 development for treatment of idiopathic pulmonary fibrosis (IPF) and other pulmonary fibrotic conditions.Total aggregate payments under the agreement have the potential to reach $444 mln, which includes option fee, an option exercise fee and subsequent clinical and regulatory milestone payments.Under terms of agreement, Bristol-Myers Squibb can exercise option to acquire Galecto at any time following execution of the transaction agreement but no later than 60 days following completion of phase 1b trial.  Full Article

FDA approves Bristol-Myers' immunotherapy for skin cancer

- The U.S. Food and Drug Administration approved Bristol-Myers Squibb Co's skin cancer drug, more than three months before the scheduled review date.

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