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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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December 17, 2014
09:41 EDTGILDActive equity options trading
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December 16, 2014
16:00 EDTGILDOptions Update; December 16, 2014
iPath S&P 500 VIX Short-Term Futures up 1.55 to 34.60. Option volume leaders: AAPL TSLA TWTR AMZN FB C GILD BAC NFLX AA MGM MCD according to Track Data.
December 12, 2014
09:35 EDTGILDActive equity options trading
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December 11, 2014
16:01 EDTGILDOptions Update; December 11, 2014
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11:55 EDTGILDGilead shares look cheap, poised for growth, Barron's says
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07:54 EDTGILDGilead shares poised to continue to advance, says RBC Capital
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December 10, 2014
15:59 EDTGILDGilead sued by SEPTA over price of Hep C drug Sovaldi, WSJ reports
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December 9, 2014
09:38 EDTGILDActive equity options trading
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08:38 EDTGILDGilead price target raised to $130 from $110 at Argus
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December 8, 2014
16:00 EDTGILDOptions Update; December 8, 2014
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10:02 EDTGILDGilead presents follow-up data from Zydelig registrational studies
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December 5, 2014
09:36 EDTGILDActive equity options trading
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07:37 EDTGILDGilead price target raised to $121 from $110 at JPMorgan
JPMorgan raised its price target for Gilead shares to $121 saying the company's potential cash flow generation is "immense" and provides "significant strategic flexibility." The firm estimates Gilead can generate more than $30B in cash in the next two years and $80B-plus over the next five years. It keeps an Overweight rating on the stock.
December 4, 2014
09:01 EDTGILDVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link

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