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January 7, 2013
07:28 EDTGILDMacroGenics and Gilead enter strategic alliance to develop DART products
MacroGenics announced it has entered into a license agreement with Gilead for the development and commercialization of Dual-Affinity Re-Targeting products directed at up to four undisclosed targets. MacroGenics' DART technology is a proprietary, bi-specific antibody platform in which a single recombinant molecule is able to target two different antigens. Under the terms of the agreement, MacroGenics could receive a total of up to $30M in license fee payments, and up to an additional $85M in pre- clinical milestones across the four DART programs. Gilead has exclusive worldwide rights for three of the programs. For one program, MacroGenics retains development and commercialization rights outside of North America, Europe, Australia and New Zealand, which encompasses multiple major markets including Japan, China, Korea, Brazil, Russia and others. Gilead will fully fund MacroGenics' research activities with respect to the four programs. MacroGenics could also receive up to approximately $1B in clinical, regulatory and commercialization milestone payments if all four programs achieve the requisite milestones.
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April 21, 2014
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
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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 (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.
April 10, 2014
13:12 EDTGILDGilead volatility increases on wide price movement
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11:44 EDTGILDStocks with call strike movement; PCLN GILD
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11:42 EDTGILDReport claims Tamiflu, Relenza do little to prevent the spread of flu
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07:24 EDTGILDInternational Society for Heart & Lung Transplantation to hold annual meeting
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05:37 EDTGILDGilead announces Phase 2 results for investigational sofosbuvir-based regimens
Gilead Sciences announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, for the treatment of chronic hepatitis C virus, or HCV, infection. The first study, ELECTRON2, is an ongoing, open-label Phase 2 clinical trial evaluating a once-daily fixed-dose combination of SOF 400 mg and the NS5A inhibitor ledipasvir, or LDV, 90 mg, with and without ribavirin, or RBV, twice-daily, among HCV-infected patient populations. In this study, 100% of treatment-na´ve genotype 3 patients receiving 12 weeks of LDV/SOF plus RBV and 64% of treatment-na´ve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy. Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100% achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65% of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV was well-tolerated, including among patients with more advanced liver disease. A second study, Study GS-US-342-0102, is an ongoing randomized Phase 2 clinical trial in which treatment-na´ve, non-cirrhotic patients with genotypes 1-6 HCV infection received a 12-week course of SOF plus the pan-genotypic NS5A inhibitor GS-5816. Patients received SOF 400 mg and either GS-5816 25 mg or GS-5816 100 mg. In this study, 94.8% of patients receiving the 25 mg dose of GS-5816 and 96.1% of patients receiving the 100 mg dose achieved SVR12.
05:32 EDTGILDGilead announces results from study of Sovaldi
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