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News Breaks
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.”
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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