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March 5, 2013
12:18 EDTGILDGilead announces 24-week Phase 2 results for once-daily HIV regimen
Gilead Sciences announced detailed 24-week results from a Phase 2 study evaluating a once-daily single tablet regimen containing tenofovir alafenamide for the treatment of HIV-1 infection. A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. These findings were presented today in a latebreaker session at the 20th Conference on Retroviruses and Opportunistic Infections taking place in Atlanta. In Study 102, HIV-positive treatment-naÔve adult patients were randomized to receive the investigational TAF-based regimen or Stribild. At 24 weeks, 87% of patients taking TAF and 90% of patients taking Stribild achieved HIV RNA less than 50 copies/mL, based on the FDA snapshot algorithm. There were no statistically significant differences in the frequency and nature of Grades 3-4 laboratory abnormalities, and the frequency and nature of adverse events were similar between the two arms. Both regimens were generally well tolerated.
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September 26, 2014
09:37 EDTGILDActive equity options trading on open
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07:20 EDTGILDGilead announces CHMP adopts 'positive opinion' for Harvoni MAA
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September 25, 2014
16:00 EDTGILDOptions Update; September 25, 2014
iPath S&P 500 VIX Short-Term Futures up 2.09 to 30.38. Option volume leaders: AAPL TSLA NFLX BAC TWTR AMZN BP PBR GILD DOW according to Track Data.
09:36 EDTGILDActive equity options trading on open
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08:42 EDTGILDGilead price target raised to $130 from $120 at Bernstein
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08:27 EDTGILDGilead viral suppression data for TAF better than expected, says UBS
UBS said the viral suppression data reported by Gilead from two studies of tenofovir alafenamide, or TAF, in HIV-1 treatment was better than expected and the firm expects the results to have a positive impact on adoption. The firm maintains its Buy rating and $125 price target on Gilead.
September 24, 2014
09:34 EDTGILDActive equity options trading on open
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09:28 EDTGILDGilead price target raised to $118 from $111 at Piper Jaffray
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08:39 EDTGILDGilead's two TAF Phase 3 trials meet primary objectives
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05:12 EDTGILDGilead submits NDA to Japan for fixed-dose combination of Ledipasvir/Sofosbuvir
Gilead Sciences announced that the company has submitted a New Drug Application, or NDA, to Japanís Pharmaceutical and Medical Devices Agency, or PMDA, for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir, or LDV, 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, 400 mg for the treatment of chronic genotype 1 hepatitis C virus, or HCV, infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naÔve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin, or RBV. LDV/SOF is currently under regulatory review in the United States and European Union.
September 23, 2014
08:07 EDTGILDFDA Pediatric Advisory Committee to hold a meeting
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September 22, 2014
09:15 EDTGILDIntercept recent weakness a buying opportunity, says Summer Street
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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.
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