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News Breaks
June 17, 2014
12:25 EDTICPT, ICPT, ICPT, GILD, GILD, GILD, RPTP, RPTP, RPTP, CNAT, CNAT, CNATSummer Street biotech analyst to hold an analyst/industry conference call
Specialty Pharma & Biotech Analyst Molloy and Chief Scientific Officer Classen, along with an MCRI consultant, provide a preview of Intercept Pharmaceuticals upcoming FLINT trial data from the NIH in July on an Analyst/Industry conference call. Relevant companies ICPT, GILD, RPTP and CNAT may be included on the Analyst/Industry conference call to be held on June 17 at 1 pm.
News For ICPT;GILD;RPTP;CNAT From The Last 14 Days
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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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16:13 EDTICPTIntercept submits applications for marketing approval of Obeticholic Acid
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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
07:09 EDTCNATConatus announces initial baseline data from Phase 2b POLT-HCV-SVR trial
Conatus announced pre-treatment biomarker and histology data from the first 16 patients enrolled in the company's Phase 2b clinical trial of its lead drug candidate, emricasan, in post-orthotopic liver transplant, or POLT, recipients. These patients have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus, or HCV, infection and have successfully achieved a sustained viral response, or SVR, following HCV antiviral therapy, or POLT-HCV-SVR. Among the first 16 patients enrolled, more than 85% achieved SVRs using recently approved oral HCV antiviral treatments. The excitement generated by these new treatments altered enrollment patterns during the early stage of the POLT-HCV-SVR trial, and their rapid market penetration is now expanding the trial-eligible population. The double-blind, placebo-controlled trial was initiated in May 2014 in patients with Ishak Fibrosis Scores of 2 to 4. Consistent with the company's initial registration focus on the development of a treatment for cirrhosis, the trial was expanded in early 2015 to include patients with Ishak 5 and is currently expanding to Ishak 6. Patients are being randomized 2:1 to receive either 25 mg of emricasan or placebo orally twice daily for 24 months and will be followed for another month post-treatment. The primary endpoint in this exploratory proof-of-concept trial is the change in the Ishak Fibrosis Score compared with placebo. The trial will also evaluate histological markers of inflammation, key serum biomarkers, and the safety and tolerability of emricasan in the target patient population. Enrollment of approximately 60 total planned patients is on track for release of final top-line results in the first half of 2018.
June 23, 2015
14:10 EDTGILDGilead price target raised to $150 from $130 at Argus
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June 22, 2015
09:40 EDTGILDActive equity options trading on open
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June 19, 2015
16:00 EDTGILDOptions Update; June 19, 2015
iPath S&P 500 VIX Short-Term Futures up 11c to 18.21, Option volume leaders: AAPL TWTR BAC T FB GILD NFLX BABA AAL MU AMZN
06:40 EDTGILDPatent linked to Gilead's Solvadi rejected by China, Reuters reports
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