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News Breaks
April 11, 2014
05:25 EDTGILDGilead announces 95% virologic suppression in HCV study
Gilead Sciences announced data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi 400 mg was administered for the treatment of chronic hepatitis C virus infection in patients with advanced liver disease. The first study, Study GS-US-334-0125, is an ongoing open-label Phase 2 clinical trial evaluating HCV patients with cirrhosis and portal hypertension, with or without decompensation, who were randomized 1:1 to an immediate treatment arm in which Sovaldi and ribavirin was administered for 48 weeks or to a deferred treatment arm in which this regimen was initiated after a 24-week observation period. Eighty percent of participants were treatment-experienced. Of the 22 patients who completed 24 weeks of therapy, 95% achieved virologic suppression on treatment. Additionally, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm. Sovaldi-based therapy was well tolerated in the study, and only one patient discontinued treatment due to an adverse event. The most common adverse events occurring in more than 25 percent of patients included nausea and pruritis.
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 Gileadís 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-naÔve 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 FDAís 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 Gileadís 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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