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May 9, 2014
16:34 EDTGILDGilead announces Phase 1 data for GS-6615
Gilead Sciences announced results from a Phase 1 clinical trial of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval in patients with long QT-3 syndrome. LQT3 is a genetic disorder that prolongs the heartís QTc interval and can cause life-threatening cardiac arrhythmias. Results from this study will be presented today in San Francisco at the annual meeting of the Heart Rhythm Society. The congenital long QT syndromes are a group of inherited disorders that affect the heartís electrical system and are characterized by irregular or rapid heartbeats that can lead to syncope, cardiac arrest or sudden cardiac death. Normal QTc intervals range from 380-460 milliseconds and LQTS patients typically have a QTc above 470 ms. LQTS symptoms can occur during strenuous exercise, emotional stimulation or sleep. The most common types are LQT1, LQT2 and LQT3. LQT3 is linked to a mutation in the gene encoding the cardiac sodium channel. Currently, there are no approved medications for patients with LQT3. In this study, ten LQT3 patients were evaluated at the Clinical Research Center at the University of Rochester, where they received single oral doses of GS-6615 ranging from 10 mg to 60 mg. The study enrolled patients with a QTc above 480 ms. The QTc pre-dose was compared to QTc on drug during time-matched 12-hour periods. In the study, QTc shortening was observed at all dose levels, with maximal QTc shortening ranging from -44 ms to -80 ms. No safety concerns were observed during administration with GS-6615. Based on these results, Gilead plans to initiate a Phase 2 study of GS-6615 in LQT3 patients later this year. Additionally, based on pre-clinical data for GS-6615 and clinical data involving the role of late sodium current inhibition in other cardiovascular diseases, Gilead plans to initiate Phase 2 clinical trials in patients with hypertrophic cardiomyopathy and ventricular tachycardia and ventricular fibrillation.
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July 29, 2015
07:25 EDTGILDGilead price target raised to $133 from $116 at JPMorgan
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06:23 EDTGILDGilead price target raised to $135 from $125 at Deutsche Bank
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06:16 EDTGILDGilead price target raised to $134 from $131 at Piper Jaffray
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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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