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Stock Market & Financial Investment News

News Breaks
April 14, 2014
08:15 EDTBMY, GILDBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
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September 25, 2014
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
12:10 EDTBMYBristol-Myers to build 650,000 square foot campus in Lawrenceville, NJ
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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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07:21 EDTBMYEBD Group to hold a conference
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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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07:43 EDTBMYBofA/Merrill to hold a conference
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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 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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