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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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September 19, 2014
11:26 EDTGILDStocks with call strike movement; TSLA GILD
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09:37 EDTGILDActive equity options trading on open
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06:25 EDTGILDGilead granted marketing aurhotization from European Commission for Zydelig
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06:11 EDTGILDGilead price target raised to $139 from $111 at Citigroup
Citigroup raised its price target for Gilead shares to $139 saying management looks "very optimistic" that FY15 hepatitis C treatment volumes could be up substantially over FY14 rates globally. Citi also expects recent buybacks to boost Q4 earnings substantially and that future stock buybacks will drive appreciation. The firm keeps a Buy rating on Gilead.
September 18, 2014
12:12 EDTGILDStocks with call strike movement; PIR GILD
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08:17 EDTGILDGilead trial failure not material, says FBR Capital
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September 17, 2014
11:52 EDTGILDStocks with call strike movement; X GILD
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06:04 EDTGILDGilead's simtuzumab Phase 2 study for pancreatic cancer does not meet endpoint
Gilead announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2, in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, the addition of simtuzumab to gemcitabine did not significantly increase progression-free survival compared to placebo plus gemcitabine. There was no difference in adverse events between patients taking simtuzumab versus placebo. Simtuzumab is being evaluated in several ongoing Phase 2 trials, including for advanced colorectal cancer, myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis, and for liver fibrosis. Other agents in Gileadís oncology pipeline are currently being evaluated in clinical trials for the treatment of pancreatic cancer.
September 15, 2014
11:56 EDTGILDStocks with call strike movement; MU GILD
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10:52 EDTGILDGilead heading for a test of support, levels to watch
The shares are down 2% to $101.54 at time of writing, putting the shares on track for a retest of the 30-day moving average at $101.21. A breakdown below that level would indicate a pickup in negative price momentum, with next support at $96.57, the 50-day moving average. A bounce from the 30-day would meet resistance at $106.93, the 10-day moving average.
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TSLA RSH YHOO GILD TWTR AVNR NFLX BAC C
06:34 EDTGILDMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
06:31 EDTGILDGilead announces licensing agreements with seven pharmaceutical companies
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September 12, 2014
14:56 EDTGILDGilead mentioned cautiously at ISI Group
September 11, 2014
11:58 EDTGILDStocks with call strike movement; DDD GILD
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September 9, 2014
09:34 EDTGILDGilead recently started cutting Sovaldi pricing by 8%, says Cleveland Research
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September 8, 2014
11:05 EDTGILDOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
09:40 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TWTR TSLA YHOO BAC FB MSFT NFLX GILD MCD
08:48 EDTGILDGilead announces AMBITION study results in collaboration with Glaxo
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