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Stock Market & Financial Investment News

News Breaks
February 8, 2013
11:45 EDTGILD, GILD, GILDGilead management to meet with Leerink
Group luncheon to be held in New York on February 12 hosted by Leerink.
News For GILD From The Last 14 Days
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April 22, 2014
07:36 EDTGILDGilead weakness has created attractive entry point, says Stifel
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April 21, 2014
16:32 EDTGILDU.S. FDA accepts Gilead's NDA's for Cobicistat and Elvitegravir
Gilead Sciences announced that the U.S. FDA has accepted the company’s refiling of two New Drug Applications for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. The FDA has set target review dates under the Prescription Drug User Fee Act of October 3 for cobicistat and October 4 for elvitegravir. Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In April 2013, the company received Complete Response Letters from the FDA. In its communications, the agency stated that it could not approve the cobicistat and elvitegravir applications in their current forms, citing deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during inspections. Gilead has worked with the FDA to address the questions raised in the Complete Response Letters. Cobicistat and elvitegravir are components of Gilead’s Stribild, a once-daily single tablet regimen for the treatment of HIV-1 infection. Stribild was approved in the United States in August 2012. Cobicistat is approved under the tradename Tybost and elvitegravir is approved under the tradename Vitekta in Europe, Canada and Australia.
16:01 EDTGILDOptions Update; April 21, 2014
iPath S&P 500 VIX Short-Term Futures down 78c to 40.03. Option volume leaders: AAPL C GILD NFLX TSLA TWTR FB WLT according to Track Data.
14:24 EDTGILDCVS wants price competition to Gilead's hepatitis C drug, Bloomberg says
CVS said it may try to slow uptake of Gilead's new hepatitis C drug, which costs $1,000 per pill. Bloomberg cites an interview with CVS's CMO Troy Brennan.
10:20 EDTGILDGilead volatility increases into Q1 and outlook
Gilead April weekly call option implied volatility is at 65, May is at 40, June is at 34, August is at 33; compared to its 26-week average of 34 according to Track Data, suggesting large near term price movement into the expected release of Q1 result son April 22.
09:36 EDTGILDActive equity options trading on open
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07:21 EDTGILDFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 17, 2014
10:11 EDTGILDHigh option volume stocks: CMG INFY GOOGL GOOG SNDK MAT YHOO BX KSU GILD
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April 16, 2014
08:34 EDTGILDPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
April 15, 2014
15:03 EDTGILDGilead treatment of chronic lymphocytic leukemia granted orphan status
The FDA granted the orphan designation on April 14, according to a post to the regulator's website. Reference Link
April 14, 2014
16:00 EDTGILDOptions Update; April 14, 2014
iPath S&P 500 VIX Short-Term Futures down 32c to 44.41. Option volume leaders: AAPL C GILD TSLA LNG NQ BAC ZNGA according to Track Data.
09:36 EDTGILDActive equity options trading on open
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09:09 EDTGILDGilead poised to be leader in all-oral HCV treatment, says Wells Fargo
After attending the EASL conference, Wells Fargo believes that Gilead's HCV treatment has multiple advantages over the competition. The firm keeps an Outperform rating on the stock.
08:15 EDTGILDBristol-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.
07:59 EDTGILDGilead Sovaldi should take majority share of HCV market, says Stifel
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07:45 EDTGILDAbbVie defended at BMO Capital
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April 11, 2014
12:04 EDTGILDStocks with call strike movement; AMZN GILD
Amazon.com (AMZN) May 380 call option implied volatility decreased 3% to 43, Gilead (GILD) August 77 call option implied volatility decreased 15% to 45 according to IVolatility.
09:37 EDTGILDActive equity options trading on open
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08:58 EDTGILDGilead valuation attractive at current levels, says RBC Capital
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05:25 EDTGILDGilead announces 95% virologic suppression in HCV study
Gilead Sciences announced data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi 400 mg was administered for the treatment of chronic hepatitis C virus infection in patients with advanced liver disease. The first study, Study GS-US-334-0125, is an ongoing open-label Phase 2 clinical trial evaluating HCV patients with cirrhosis and portal hypertension, with or without decompensation, who were randomized 1:1 to an immediate treatment arm in which Sovaldi and ribavirin was administered for 48 weeks or to a deferred treatment arm in which this regimen was initiated after a 24-week observation period. Eighty percent of participants were treatment-experienced. Of the 22 patients who completed 24 weeks of therapy, 95% achieved virologic suppression on treatment. Additionally, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm. Sovaldi-based therapy was well tolerated in the study, and only one patient discontinued treatment due to an adverse event. The most common adverse events occurring in more than 25 percent of patients included nausea and pruritis.
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