Key Developments: Bristol-Myers Squibb Co (BMY)

BMY on New York Consolidated

17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Squibb Co submits NDA to US FDA for fixed-dose combination tablet of Atazanavir Sulfate with Cobicistat for people living with HIV-1
Monday, 14 Apr 2014 08:00am EDT 

Bristol-Myers Squibb Co:Submission of NDA to US FDA.For fixed-dose combination tablet of Atazanavir Sulfate with Cobicistat for people living with HIV-1.If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet.Cobicistat is being developed by Gilead Sciences Inc.  Full Article

Bristol-Myers Squibb Co presents phase III data, Asunaprevir Therapy achieved SVR12 Rates of up to 90 pct
Thursday, 10 Apr 2014 07:00am EDT 

Bristol-Myers Squibb Co:Results of the HALLMARK-Dual study include data among genotype 1b cirrhotic and non-cirrhotic, treatment-na├»ve, non-responder, and peginterferon/ribavirin ineligible and intolerant patients.Phase III results from investigating all-oral, interferon- and ribavirin-free regimen of daclatasvir, a NS5A inhibitor, and asunaprevir , a NS3 inhibitor, among genotype 1b hepatitis C virus infected patients.Results showed that 24-week regimen achieved an overall sustained virologic response 12 weeks after end of treatment.In the study DCV+ASV regimen was generally well tolerated.  Full Article

Bristol-Myers Squibb submits NDAs for Daclatasvir and Asunaprevir to US FDA for the treatment of Hepatitis C
Monday, 7 Apr 2014 08:00am EDT 

Bristol-Myers Squibb Co:Submits new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV).Data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV).DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes.  Full Article

Oncolys Biopharma cancels exclusive license agreement with Bristol-Myers Squibb
Friday, 4 Apr 2014 02:00am EDT 

Oncolys Biopharma Inc:Canceled the exclusive license agreement signed with Bristol-Myers Squibb on Dec. 14, 2010.License granted by the company for Bristol-Myers Squibb to conduct clinical trial for OBP-601, the phase IIb trial agent for enzyme inhibiting agents.  Full Article

Five Prime Therapeutics Inc and Bristol-Myers Squibb sign collaboration agreement
Monday, 17 Mar 2014 06:59am EDT 

Five Prime Therapeutics Inc and Bristol-Myers Squibb Company:Signs collaboration agreement for discovery, development and commercialization of immuno-oncology therapies.Says directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime's proprietary target discovery platform.  Full Article

Bristol-Myers Squibb Co declares dividend
Monday, 3 Mar 2014 04:30pm EST 

Bristol-Myers Squibb Co:Declares quarterly dividend of $0.36 per share.Payable on May 1 to stockholders of record at the close of business on Apr. 4.  Full Article

Bristol-Myers Squibb Co Receives U.S. FDA therapy designation for all-oral daclatasvir dual investigational regimen for Chronic Hepatitis C
Tuesday, 25 Feb 2014 05:59am EST 

Bristol-Myers Squibb Co:U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).Saus designation is based on data from the company's ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.  Full Article

Bristol-Myers Squibb Co and Pfizer Inc. announces data from phase 3 ARISTOTLE trial pre-specified subanalysis
Friday, 21 Feb 2014 11:06am EST 

Bristol-Myers Squibb Co and Pfizer Inc:Says results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age.Subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events.Owing to the higher risk at older age (age 75 and older), the absolute benefit to patients with NVAF was greater with Eliquis in the older population.Eliquis was more effective than warfarin in reducing the risk of stroke and reducing mortality across age groups, and was associated with less major bleeding, less total bleeding and less intracranial hemorrhage, regardless of age.The p-value for interaction across age groups was non-significant (p>0.11 for all) for the major outcomes of stroke and systemic embolism, major bleeding, and death, meaning that the results of this subanalysis were consistent with the overall results of the ARISTOTLE trial.  Full Article

Bristol-Myers Squibb Co completes previously announced sale of global diabetes business to AstraZeneca
Monday, 3 Feb 2014 02:00am EST 

Bristol-Myers Squibb Co:Says it has completed the previously announced sale of its global diabetes business to AstraZeneca.Receives from AstraZeneca a payment of about $2.7 bln in connection with the closing, and will receive by mid-February, a $0.6 bln payment from the recent U.S. approval of Farxiga (dapagliflozin).Says under terms of the agreement, Bristol-Myers Squibb will also receive from AstraZeneca potential regulatory and sales-based payments of up to $0.8 bln, and royalty payments based on net sales through 2025.Says AstraZeneca will make payments of up to $225 mln if and when certain assets are subsequently transferred.Says the transaction includes the rights to Bristol-Myers Squibb's global diabetes business that was part of its collaboration with AstraZeneca, the former Amylin manufacturing facility in West Chester, Ohio.Says also covers the future purchase by AstraZeneca of Bristol-Myers Squibb's Mount Vernon, Indiana, manufacturing facility, no earlier than 18 months following the closing date.Says the closing of the transaction as it relates to China remains subject to the satisfaction of certain conditions in the Sino-American Shanghai Squibb Pharmaceutical Company joint venture agreement between Bristol-Myers Squibb China and its joint venture partners.  Full Article

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

Bristol-Myers Squibb Co:Expects FY 2014 GAAP EPS in the range of $1.75-$1.90.Reaffirmed FY 2014 Non-GAAP EPS in the range of $1.65-$1.80.FY 2014 EPS of $1.78 - Thomson Reuters I/B/E/S.  Full Article

Bristol-Myers hepatitis C treatment cures up to 90 percent: study

- A combination of two anti-viral drugs developed by Bristol-Myers Squibb Co cured 90 percent of previously untreated hepatitis C patients and 82 percent of those who failed to respond to prior therapy, according to results from a late stage study presented on Thursday.

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