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News Breaks
July 25, 2014
07:25 EDTGILDGilead receives positive opinion from CHMP for Zydelig
Gilead Sciences announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma, the most common subtype of indolent non-Hodgkin lymphoma. The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. The CHMP positive opinion for Zydelig is based on data from two clinical trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.
News For GILD From The Last 14 Days
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January 30, 2015
14:33 EDTGILDAbbVie comments affirm 25/75 HCV market split with Gilead, says Wells Fargo
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14:26 EDTGILDGilead Q4 HCV sales should meet consensus, says BofA/Merrill
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07:57 EDTGILDGilead February weekly volatility elevated into Q4 and outlook
Gilead February weekly call option implied volatility is at 79, February is at 35, March is at 31, April is at 30; compared to its 26-week average of 34 according to Track Data, suggesting large near term price movement into the expected release of Q4 results on February 3.
January 29, 2015
09:37 EDTGILDActive equity options trading
Active equity options trading according to Track Data: AAPL FB KO NFLX PFMT GILD YHOO TSLA MCD
08:44 EDTGILDUnitedHealth selects Gilead's Harvoni for hepatitis C coverage, Reuters says
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January 28, 2015
09:35 EDTGILDActive equity options trading
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January 27, 2015
16:00 EDTGILDOptions Update; January 27, 2015
iPath S&P 500 VIX Short-Term Futures up 1.40 to 32.01. Option volume leaders: AAPL TSLA TWTR AMZN FB MSFT X RIG YHOO C GILD according to Track Data.
09:36 EDTGILDActive equity options trading
Active equity options trading according to Track Data: AAPL MSFT TWTR TSLA GILD NFLX C AA HPQ X
08:53 EDTGILDGilead February weekly volatility elevated into Q4 and outlook
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January 26, 2015
16:01 EDTGILDOptions Update; January 26, 2015
iPath S&P 500 VIX Short-Term Futures down 1.47 to 30.63. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX X MSFT BP GILD according to Track Data.
13:01 EDTGILDGilead, EnvisionRx sign exclusive agreement for Sovaldi, Harvoni availability
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11:00 EDTGILDMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
09:49 EDTGILDActive equity options trading
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05:11 EDTGILDGilead expands hepatitis C generic licensing agreements
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January 23, 2015
09:35 EDTGILDGilead mentioned cautiously at Cleveland Research
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January 20, 2015
16:00 EDTGILDOptions Update; January 20, 2015
iPath S&P 500 VIX Short-Term Futures down 36c to 35.12 Option volume leaders: AAPL TSLA TWTR GILD NFLX MGM ABX AMAT JNJ C according to Track Data.
09:38 EDTGILDActive equity options trading
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