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News Breaks
April 14, 2014
08:15 EDTBMY, GILDBristol-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.
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July 24, 2014
05:26 EDTBMYBristol-Myers, Ono Pharmaceutical announces strategic collaboration in Japan
Bristol-Myers Squibb and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo and Yervoy across a broad range of tumor types. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.
July 23, 2014
16:13 EDTGILDGilead raises FY14 net product sales guidance to $21B-$23B from $11.3B-$11.5B
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16:09 EDTGILDGilead reports Q2 product revenue $6.41B vs. $2.66B last year
Reports Q2 Royalty, contract, and other revenues $122M vs. 110.1M last year. John C. Martin, PhD, Gilead’s chairman and CEO stated, “During Q2, Gilead continued to make significant progress led by strong Sovaldi sales. Since December’s launch, Sovaldi has been prescribed for more than 80,000 patients in the U.S. and Europe, underscoring the medical community’s recognition of the benefits of this product. We look forward to making Sovaldi available in additional countries.”
16:05 EDTGILDGilead reports Q2 EPS $2.36, consensus $1.79
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16:01 EDTGILDGilead trading halted, pending news
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16:00 EDTGILDOptions Update; July 23, 2014
iPath S&P 500 VIX Short-Term Futures up 23c to 28.17. Option volume leaders: AAPL FB C GILD MSFT PBR NFLX AMZN TWTR TSLA according to Track Data
15:43 EDTGILDGilead July weekly 90 straddle priced for 5.5% move into Q2
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15:30 EDTBMYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Ford (F), consensus 36c; General Motors (GM), consensus 58c; Potash (POT), consensus 46c; Caterpillar (CAT), consensus $1.52; 3M (MMM), consensus $1.91; Union Pacific (UNP), consensus $1.43; Bristol-Myers Squibb (BMY), consensus 44c; Eli Lilly (LLY), consensus 65c; Celgene (CELG), consensus 89c; Precision Castparts (PCP), consensus $3.35; Raytheon (RTN), consensus $1.59; Noble Energy (NBL), consensus 79c; Hershey (HSY), consensus 76c; Southwest Airlines (LUV), consensus 61c; Boston Scientific (BSX), consensus 19c; JetBlue (JBLU), consensus 19c.
15:30 EDTGILDNotable companies reporting after market close
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15:10 EDTBMYBristol-Myers technical comments before earnings
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11:40 EDTGILDFDA approves Zydelig for three types of blood cancers
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July 22, 2014
06:14 EDTGILDGilead July weekly volatility elevated into Q2
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July 21, 2014
16:00 EDTGILDOptions Update; July 21, 2014
iPath S&P 500 VIX Short-Term Futures up 65c to 28.53. Option volume leaders: AAPL FB NFLX DG CMCSA GILD PBR TWTR TSLA according to Track Data.
09:38 EDTGILDActive equity options trading on open
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07:21 EDTGILDGilead could be hurt by new HCV drugs, says Wells Fargo
Noting that data on a new Merck (MRK) HCV treatment is expected in November, Wells Fargo thinks Merck's HCV drug could be combined with Gilead's (GILD) Sovaldi to shorten the duration of treatment to four weeks. Other companies could take similar actions, and Gilead's per patient revenues would be significantly reduced if this occurs, the firm warned. However, it continues to have an upbeat outlook on Gilead heading into what it sees as a strong quarter and is still upbeat on the company's long-term HCV opportunity. It keeps an Outperform rating on Gilead.
06:43 EDTGILD, BMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
12:46 EDTGILDGilead drug cocktail helps treat HIV/HCV-coinfected patients, JAMA says
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July 17, 2014
08:08 EDTBMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
11:57 EDTGILDStocks with call strike movement; GILD YHOO
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06:26 EDTBMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
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