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News Breaks
April 14, 2014
08:15 EDTGILD, BMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. 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 (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
News For BMY;GILD From The Last 14 Days
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April 21, 2015
10:00 EDTGILDGilead spikes higher, levels to watch
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09:37 EDTGILDActive equity options trading on open
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08:14 EDTGILDGilead should buy Vertex, says Bernstein
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06:58 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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06:44 EDTBMYBristol-Myers upgraded on early Opdivo success at Morgan Stanley
As previously reported, Morgan Stanley upgraded Bristol-Myers to Overweight from Equal Weight. The firm raised estimates above consensus and increased its price target on the stock to $80 from $60 following confirmation of Opdivo's survival benefits in lung cancer. Morgan Stanley expects Opdivo to be one of the top three pharma-bio launches over the next several years and notes Bristol is ahead of the competition in immuno-oncology combination drug development.
06:15 EDTBMYBristol-Myers upgraded to Overweight from Equal Weight at Morgan Stanley
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April 20, 2015
09:36 EDTGILDActive equity options trading on open
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08:12 EDTBMYVanda names Tom Gibbs as SVP and Chief Commercial OfficerBristol-Myers
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07:20 EDTGILD, BMYAmerican Association for Cancer Research to hold annual meeting
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April 17, 2015
09:41 EDTBMYBristol-Myers up after Phase III Opdivo study met endpoint, trial stopped early
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09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
16:01 EDTGILDOptions Update; April 15, 2015
iPath S&P 500 VIX Short-Term Futures down 49c to 21.90. Option volume leaders: AAPL NFLX C PBR KMI RIG MCP TWTR GILD BAC according to Track Data.
09:08 EDTBMYOn The Fly: Pre-market Movers
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07:41 EDTBMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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