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

BMYMP.PK on OTC Markets Group

1,018.82USD
29 Jan 2015
Change (% chg)

-- (--)
Prev Close
$1,018.82
Open
--
Day's High
--
Day's Low
--
Volume
--
Avg. Vol
1
52-wk High
$1,079.17
52-wk Low
$750.00

Search Stocks

Latest Key Developments (Source: Significant Developments)

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

Bristol-Myers Squibb and Lonza expand manufacturing agreement
Thursday, 30 Oct 2014 01:00pm EDT 

Bristol-Myers Squibb Co:Says the company and Lonza announced a multi-year expansion of their existing biologics manufacturing agreement.Says the contract expansion will include the production of commercial quantities of a second Bristol-Myers Squibb biologic medicine at Lonza's mammalian manufacturing facility in Portsmouth, New Hampshire.Bristol-Myers Squibb and Lonza have been collaborating since 2003 to produce commercial supplies of a biologics medicine marketed by Bristol-Myers Squibb worldwide.Currently, Lonza also produces clinical supplies of an investigational biologics medicine for Bristol-Myers Squibb.  Full Article

Bristol-Myers Squibb Co enters into agreement that provides an exclusive option to acquire F-star Alpha Ltd
Tuesday, 28 Oct 2014 07:00am EDT 

Bristol-Myers Squibb Co:Bristol-Myers Squibb Company and F-star Alpha Ltd. announces that companies, together with F-star Alpha Ltd. shareholders.Enters into an agreement that provides Bristol-Myers Squibb the exclusive option to acquire F-star Alpha Ltd, and gain worldwide rights to its lead asset FS102.FS102 is a novel Phase 1 ready H uman E pidermal growth factor R eceptor 2 (HER2)-targeted therapy in development for the treatment of breast and gastric cancer among a well-defined population of HER2-positive patients who do not respond or become resistant to current therapies.Under terms of agreement, Bristol-Myers Squibb will make payments aggregating to $50 mln that consist of an option fee for the right to acquire F-star Alpha Ltd., payment for certain rights and licenses from F-star Alpha Ltd. and clinical milestne payment upon initiation of the Phase 1 trial.Bristol-Myers Squibb will be responsible for conducting and funding development of FS102 during the option period. Bristol-Myers Squibb can exercise the option to acquire F-star Alpha Ltd. in its sole discretion upon its decision to commence a Phase 2b trial.Total aggregate consideration may reach $475 mln, which includes the payments aggregating to $50 mln, the option exercise fee, and payments upon the commencement of Phase 3 clinical trial and regulatory approvals in the U.S. and Europe.  Full Article

Bristol-Myers Squibb Co reaffirms FY 2014 EPS guidance
Friday, 24 Oct 2014 07:30am EDT 

Bristol-Myers Squibb Co:Says that it is adjusting its FY 2014 GAAP EPS guidance range to $1.15 - $1.25 from $1.50 - $1.60 and confirming its non-GAAP EPS guidance range of $1.70 - $1.80.FY 2014 EPS of $1.78 - Thomson Reuters I/B/E/S.  Full Article

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

FDA approves Bristol-Myers, J&J HIV pills

- The U.S. Food and Drug Administration on Thursday approved two fixed-dose HIV pills that combine protease inhibitors - one made by Bristol-Myers Squibb Co and the other by Johnson & Johnson - both with a boosting agent produced by Gilead Sciences Inc.

Search Stocks