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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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July 6, 2015
13:40 EDTGILDGilead's advances after Harvoni gets approval in Japan
Late last week, Gilead Sciences announced that the Japanese Ministry of Health, Labour and Welfare, MHLW, had approved Harvoni, the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi in March. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus, HCV, infection with or without compensated cirrhosis, with a treatment duration of 12 weeks. Shares of Gilead are up 0.51% in an otherwise negative day for the markets.
July 2, 2015
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL HP TSLA FB GRPN BP MEP GILD
July 1, 2015
16:33 EDTGILDGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDA’s acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 30, 2015
11:58 EDTGILDStocks with call strike movement; GILD YHOO
Gilead (GILD) November 130 call option implied volatility increased 2% to 28, Yahoo (YHOO) October 46 call option implied volatility decreased 2% to 29 according to IVolatility.
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB GILD BABA BAC MU WYNN MSFT NFLX
07:32 EDTGILDJuno pact leaves Celgene set for growth past Revlimid, says Deutsche Bank
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June 29, 2015
16:30 EDTGILDFDA sued by advocacy groups for Gilead Hep-C drug trial data, Reuters says
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June 25, 2015
09:34 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB NFLX AMZN BAC CVX TWTR INTC GILD BBBY
June 23, 2015
14:10 EDTGILDGilead price target raised to $150 from $130 at Argus
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