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May 9, 2014
16:34 EDTGILDGilead announces Phase 1 data for GS-6615
Gilead Sciences announced results from a Phase 1 clinical trial of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval in patients with long QT-3 syndrome. LQT3 is a genetic disorder that prolongs the heartís QTc interval and can cause life-threatening cardiac arrhythmias. Results from this study will be presented today in San Francisco at the annual meeting of the Heart Rhythm Society. The congenital long QT syndromes are a group of inherited disorders that affect the heartís electrical system and are characterized by irregular or rapid heartbeats that can lead to syncope, cardiac arrest or sudden cardiac death. Normal QTc intervals range from 380-460 milliseconds and LQTS patients typically have a QTc above 470 ms. LQTS symptoms can occur during strenuous exercise, emotional stimulation or sleep. The most common types are LQT1, LQT2 and LQT3. LQT3 is linked to a mutation in the gene encoding the cardiac sodium channel. Currently, there are no approved medications for patients with LQT3. In this study, ten LQT3 patients were evaluated at the Clinical Research Center at the University of Rochester, where they received single oral doses of GS-6615 ranging from 10 mg to 60 mg. The study enrolled patients with a QTc above 480 ms. The QTc pre-dose was compared to QTc on drug during time-matched 12-hour periods. In the study, QTc shortening was observed at all dose levels, with maximal QTc shortening ranging from -44 ms to -80 ms. No safety concerns were observed during administration with GS-6615. Based on these results, Gilead plans to initiate a Phase 2 study of GS-6615 in LQT3 patients later this year. Additionally, based on pre-clinical data for GS-6615 and clinical data involving the role of late sodium current inhibition in other cardiovascular diseases, Gilead plans to initiate Phase 2 clinical trials in patients with hypertrophic cardiomyopathy and ventricular tachycardia and ventricular fibrillation.
News For GILD From The Last 14 Days
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October 14, 2014
10:05 EDTGILDAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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09:37 EDTGILDActive equity options trading on open
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09:14 EDTGILDJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
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October 13, 2014
16:02 EDTGILDOptions Update; October 13, 2014
iPath S&P 500 VIX Short-Term Futures up 3.71 to 39.56. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX SUNE GILD BAC PBR according to Track Data.
09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
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08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
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07:56 EDTGILDGilead Harvoni pricing 'very reasonable,' says RBC Capital
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07:39 EDTGILDPharmaceutical Care Management Association to hold annual meeting
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October 10, 2014
14:08 EDTGILDGilead 12-week regimen of Harvoni to cost $94.5K
Gilead said its newly-approved treatment of hepatitis C genotype 1 infection, Harvoni, will be priced at $94,500 for a full 12 week regiment, according to multiple media outlets, which cite a company spokesperson.
13:55 EDTGILDGilead confirms FDA approval of Harvoni
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13:42 EDTGILDGilead hepatitis C treatment Harvoni approved by FDA
The FDA announced the approval of Harvoni to treat chronic hepatitis C virus genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, the agency stated. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, it added. Harvoni is marketed by Gilead.
13:40 EDTGILDFDA approves Gilead hepatitus C treatment Harvoni
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08:19 EDTGILDMedivir announces Janssen initiates enrolment in phase II IMPACT study
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07:21 EDTGILDFDA PDUFA Date for Gilead Sciences Sofosbuvir is October 10, 2014
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October 9, 2014
11:43 EDTGILDStocks with call strike movement; GILD EWZ
Gilead (GILD) February 120 call option implied volatility increased 3% to 38, MSCI Brazil Index (EWZ) February 58 call option implied volatility increased 3% to 38 according to IVolatility.
08:28 EDTGILDGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
16:26 EDTGILDOn The Fly: Closing Wrap
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16:01 EDTGILDOptions Update; October 8, 2014
iPath S&P 500 VIX Short-Term Futures down 2.73 to 29.51. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX PBR AA CLF GILD according to Track Data.
15:49 EDTGILDAchillion, Gilead rise after late breaking abstract for AASLD posted
Shares of Achillion (ACHN) are higher after the company announced this morning that four abstracts have been accepted for presentation at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases. Among those four is a late breaker poster presentation providing updated results, including SVR12, from an ongoing Phase 2 proxy study evaluating Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naÔve genotype 1 chronic hepatitis C virus infection. Sofosbuvir is sold under the brand name Sovaldi by Gilead Sciences (GILD). In a note to investors, FBR Capital noted that the "surprise" late-breaking poster for the meeting showed a 100% cure rate for the combination therapy. In late afternoon trading, Achillion shares are up 10% to $10.74 while Gilead is up 4.3% to $108.78.
07:18 EDTGILDInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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