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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.
News For GILD From The Last 14 Days
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April 24, 2015
09:37 EDTGILDActive equity options trading on open
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08:33 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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April 23, 2015
16:01 EDTGILDOptions Update; April 23, 2015
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07:59 EDTGILDMylan launches generic sofosbuvir tablets in India
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05:19 EDTGILDGilead Harvoni, Sovaldi demonstrate efficacy, safety
Gilead Sciences announced results from several Phase 2 clinical studies evaluating investigational uses of Harvoni and other Sovaldi-based regimens for the treatment of chronic hepatitis C virus, or HCV, infection in patients with advanced liver disease, including patients with decompensated cirrhosis, patients with fibrosing cholestatic hepatitis C and patients with portal hypertension. In SOLAR-2, 328 genotype 1 or 4 HCV patients with decompensated liver disease before liver transplantation or recurrent HCV infection following liver transplantation were randomized to receive either 12 or 24 weeks of Harvoni plus ribavirin. Ten patients were excluded from the analysis because of transplantation or because they were pre-transplantation, but not decompensated; an additional 27 of these patients have not yet reached post-treatment week 12. The most common adverse events were fatigue, anemia, nausea and headache. Overall, six patients discontinued treatment due to adverse events, five of whom had decompensated cirrhosis.
05:16 EDTGILDGilead data supports ongoing trials evaluating shortened course of therapy
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April 22, 2015
07:07 EDTGILDEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
April 21, 2015
16:00 EDTGILDOptions Update; April 21, 2015
iPath S&P 500 VIX Short-Term Futures down 1c to 21.53 Option volume leaders: AAPL TSLA TWTR GILD FB PBR AMZN C KMI KO VZ MCD according to Track Data.
13:34 EDTGILDGilead paying premium to buy Vertex not warranted right now, says Maxim
After Bernstein suggested in a note to investors earlier that Gilead (GILD) should buy Vertex (VRTX), Maxim responded in its own note that it does not believe paying a premium to buy Vertex makes sense before the company has data showing efficacy for Kalydeco in heterozygotes. Maxim keeps a Hold rating and $121 price target on Vertex shares.
12:33 EDTGILDOn The Fly: Top stock stories at midday
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12:21 EDTGILDVertex rises after Bernstein suggests Gilead should pursue takeover
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10:00 EDTGILDGilead spikes higher, levels to watch
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09:37 EDTGILDActive equity options trading on open
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08:14 EDTGILDGilead should buy Vertex, says Bernstein
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06:58 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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April 20, 2015
09:36 EDTGILDActive equity options trading on open
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07:20 EDTGILDAmerican Association for Cancer Research to hold annual meeting
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April 15, 2015
16:01 EDTGILDOptions Update; April 15, 2015
iPath S&P 500 VIX Short-Term Futures down 49c to 21.90. Option volume leaders: AAPL NFLX C PBR KMI RIG MCP TWTR GILD BAC according to Track Data.
April 13, 2015
16:01 EDTGILDOptions Update; April 13, 2015
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09:34 EDTGILDActive equity options trading on open
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