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News Breaks
February 19, 2013
08:32 EDTGILDGilead's Sofosbuvir for hepatitis C meets primary endpoint in Phase 3 study
Gilead Sciences announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response rate of 25%. In FUSION, 50% of patients in the 12-week arm and 73% of patients in the 16-week arm achieved SVR12. “This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”
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April 27, 2015
07:38 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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April 26, 2015
14:56 EDTGILDGilead reports 'high cure rates' for Sovaldi in genotype 2-5 hep C patients
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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.
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