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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.
News For BMY;GILD From The Last 14 Days
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October 15, 2014
07:30 EDTGILDGilead headlines on taxes, price war create buying opportunity, says UBS
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October 14, 2014
16:22 EDTGILDOn The Fly: Closing Wrap
The Wall Street averages were mixed after three of the U.S.'s largest banks reported on their quarterly results and Germany slashed its economic forecasts for this year and next. Following the mostly solid earnings reports from the banks and Dow member Johnson & Johnson (JNJ) investors appeared to breathe a sigh of relief and sent the averages higher in early trading. With oil prices falling almost 5% and settling at a recent low, the averages pared their gains and struggled in positive ground. Another late day slide ended with the averages mixed, as the Nasdaq led and the Dow lagged. ECONOMIC EVENTS: In the U.S., the International Energy Agency said in its monthly oil market report that world oil demand growth would be weaker than previously expected. Afterward, WTI crude oil futures fell 4.6% at $81.84, marking their biggest percentage drop since late 2012 and the lowest settlement for the benchmark in over two years. The National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. In Europe, Germany's government cut its forecasts for gross domestic product growth to 1.2% in 2014 and 1.3% next year from its prior view of 1.8% growth this year and 2% in 2015. COMPANY NEWS: The first of America's big banks issued their quarterly reports, with JPMorgan's (JPM) headline earnings per share coming in below analysts’ consensus estimate, Wells Fargo (WFC) reporting in-line earnings and improved credit quality and Citigroup (C) posting better than expected adjusted third quarter profit. Citi, which also announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit after an investigation uncovered illegal conduct, saw its stock fare the best among the three, rising $1.57, or 3.15%, to $51.47... Another Dow member, Johnson & Johnson, reported better than expected profits and revenues and raised its FY14 EPS outlook, but its stock slid $2.11, or 2.13%, to $97.01. MAJOR MOVERS: Among the notable gainers was Domino's Pizza (DPZ), which rose $8.58, or 11.33%, to $84.30 after the pizza chain owner and franchisor reported better than expected third quarter earnings per share and revenue. Also higher was Skyworks (SWKS), which advanced $3.59, or 7.92%, to $48.91 after the supplier of chips to Apple (AAPL) raised its fourth quarter earnings per share outlook and revenue guidance. Among the noteworthy losers was Exactech (EXAC), which dropped $4.09, or 16.63%, to $20.50 after the company warned its Q3 income and revenue will likely miss its prior guidance. Also lower were shares of Gilead (GILD), which fell $4.26, or 4.2%, to $97.18 amid a number of developments. Competitor Johnson & Johnson said it would seek to make its own hepatitis C treatment accessible and "competitive," which some may have read as an indication of a potential price cut, and Ireland said it plans to close its "Irish Double" tax loophole, which currently benefits Gilead. INDEXES: The Dow slipped 5.88, or 0.04%, to 16,315.19, the Nasdaq rose 13.52, or 0.32%, to 4,227.17, and the S&P 500 added 2.96, or 0.16%, to 1,877.70.
16:00 EDTGILDOptions Update; October 14, 2014
iPath S&P 500 VIX Short-Term Futures down 40c to 39.11. Option volume leaders: AAPL TSLA TWTR AMZN GILD C JNJ AA NFLX PBR according to Track Data.
12:41 EDTGILDGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
11:52 EDTGILDStocks with call strike movement; APC GILD
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11:23 EDTBMYBIND Therapeutics and The Conference Forum hold a conference
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11:10 EDTGILDGilead weakness today overdone, says Deutsche Bank
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10:51 EDTGILDGilead weakness a buying opportunity, says RBC Capital
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10:41 EDTGILDGilead weakness a buying opportunity, says RBC Capital
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10:11 EDTGILDGilead volatility increases on wide price movement
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10:05 EDTGILDAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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09:37 EDTGILDActive equity options trading on open
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09:14 EDTGILDJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
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October 13, 2014
16:02 EDTGILDOptions Update; October 13, 2014
iPath S&P 500 VIX Short-Term Futures up 3.71 to 39.56. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX SUNE GILD BAC PBR according to Track Data.
09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
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08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
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08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered 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 OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The 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, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:56 EDTGILDGilead Harvoni pricing 'very reasonable,' says RBC Capital
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07:39 EDTGILDPharmaceutical Care Management Association to hold annual meeting
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07:13 EDTBMYBioFlorida to hold a conference
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