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March 22, 2013
08:31 EDTGILDGilead says CHMP adopts positive opinion for Stribild
Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the companyís Marketing Authorization Application for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naÔve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada. The CHMPís positive recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the European Union. Stribild has received marketing approval in the United States, Canada, South Korea and Australia.
News For GILD From The Last 14 Days
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November 24, 2015
09:37 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB BAC DIS NFLX X YNDX GILD PANW SUNW
November 23, 2015
09:39 EDTGILDActive equity options trading on open
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06:41 EDTGILDGilead granted marketing authorization in EU for Genvoya
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November 18, 2015
09:34 EDTGILDActive equity options trading on open
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November 17, 2015
10:47 EDTGILDBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
November 16, 2015
09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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