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January 7, 2013
08:47 EDTGILDGilead updates on Hepatitis C development programs
Gilead Sciences announced several updates regarding its late-stage pipeline candidates for the treatment of chronic hepatitis C virus infection. The company released new results from an arm of the ongoing Phase 2 ELECTRON study examining the nucleotide sofosbuvir and the NS5A inhibitor GS-5885, and provided a progress report on a range of Phase 2 and 3 clinical trials evaluating a once-daily fixed-dose combination tablet of these medicines. Gilead announced full data from one cohort of the ongoing Phase 2 ELECTRON study examining a 12-week course of all-oral therapy with sofosbuvir, GS-5885 and ribavirin among genotype 1 HCV patients who had previously failed to respond to an interferon-containing regimen, or “null responders.” Preliminary data, presented in November at the annual meeting of the American Association for the Study of Liver Diseases, demonstrated that three of nine patients remained HCV RNA undetectable four weeks after completing therapy. Today’s announcement confirms that all nine patients in this cohort achieved SVR4. These patients will continue to be observed to determine sustained virologic response rates at weeks 12 and 24 of follow-up. Results from eight other arms of the ELECTRON study, evaluating sofosbuvir alone and with RBV and/or pegylated IFN, were published earlier this month in the New England Journal of Medicine, the company said. The company also said these updates will be highlighted today as part of Gilead’s corporate presentation at the 31st Annual J.P. Morgan Healthcare Conference taking place in San Francisco. “Since the acquisition of Pharmasset only a year ago, we have fully enrolled four Phase 3 studies of sofosbuvir and during the first quarter of this year we will have initiated two Phase 3 studies of the sofosbuvir and GS-5885 fixed-dose combination,” said Norbert Bischofberger, PhD, Chief Scientific Officer, Gilead Sciences. “We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014.”
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July 28, 2015
16:08 EDTGILDGilead up almost 4% following better than expected Q2 results
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16:05 EDTGILDGilead narrows FY15 adj product gross margin view to 88%-90% from 87%-90%
16:04 EDTGILDGilead reports Q2 antiviral product sales increased to $7.6B
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16:03 EDTGILDGilead reports Q1 total product sales $8.1B
Total product sales for the second quarter of were $8.1B compared to $6.4B for the second quarter of 2014. Product sales in the U.S. were $5.6B compared to $4.8B for the second quarter of 2014. In Europe, product sales were $2B compared to $1.3B for the same period in 2014.
16:02 EDTGILDGilead raises FY15 net product sales view to $29B-$30B from $28B-$29B
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16:01 EDTGILDGilead reports Q2 adjusted EPS $3.15, consensus $2.71
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15:47 EDTGILDGilead July weekly 112 straddle priced for 6% movement
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15:21 EDTGILDNotable companies reporting after market close
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13:39 EDTGILDGilead technical notes before results
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11:42 EDTGILDStocks with call strike movement; FB GILD
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July 27, 2015
11:57 EDTGILDStocks with call strike movement; FB GILD
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08:42 EDTGILDGilead July weekly volatility increases into Q2 and outlook
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05:56 EDTGILDStocks with implied volatility movement; CRM GILD
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July 24, 2015
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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July 23, 2015
12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
July 20, 2015
07:33 EDTGILDInternational AIDS Society to hold a conference
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July 17, 2015
10:21 EDTGILDCigna says 98.4% of customers treated with hep C drug Harvoni are cured
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09:03 EDTGILDGilead granted orphan status for gastric cancer treatment
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July 16, 2015
09:22 EDTGILDBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
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