Key Developments: Gilead Sciences Inc (GILD.O)

GILD.O on Nasdaq

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

ONO PHARMACEUTICAL CO LTD signs exclusive license agreement with Gilead Sciences, Inc
Friday, 19 Dec 2014 01:00am EST 

ONO PHARMACEUTICAL CO LTD:Entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases.Gilead will pay ONO an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones.The companies will collaborate jointly on global development of ONO-4059.Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.  Full Article

Gilead Sciences prices $4 billion of senior unsecured notes
Wednesday, 12 Nov 2014 05:59pm EST 

Gilead Sciences Inc:Says pricing of senior unsecured notes in an aggregate principal amount of $4 billion, in an underwritten, registered public offering, consisting of three tranches.Says $500 million of 2.350% senior notes maturing in Feb. 2020.Says $1,750 million of 3.500% senior notes maturing in Feb. 2025.Says $1,750 million of 4.500% senior notes maturing in Feb. 2045.Says senior notes are rated A- by Standard & Poor's and A3 by Moody's.Says offering is expected to close Nov. 17, 2014.  Full Article

Gilead Sciences Inc announces phase 2 data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for treatment of chronic Hepatitis C
Tuesday, 11 Nov 2014 08:00am EST 

Gilead Sciences Inc:Says data from three Phase 2 open-label studies evaluating the safety and efficacy of an investigational all-oral pan-genotypic regimen containing nucleotide analog polymerase inhibitor sofosbuvir (SOF).Approved as Sovaldi by the U.S. Food and Drug Administration in Dec. 2013, and the investigational NS5A inhibitor GS-5816 for the treatment of chronic hepatitis C virus (HCV) infection.All three studies evaluated SOF 400 mg plus GS-5816 25 or 100 mg, with and without ribavirin (RBV), for eight or 12 weeks.Rates of sustained virologic response (SVR12) ranged from 88 pct to 100 pct among those receiving SOF plus GS-5816 100 mg for 12 weeks - the regimen selected for Phase 3 studies.Patients who achieve SVR12 are considered cured of HCV infection.  Full Article

Gilead Sciences Inc announces Harvoni Study Results in Chronic Hepatitis C patients with advanced liver disease and those who failed prior treatment
Tuesday, 11 Nov 2014 08:00am EST 

Gilead Sciences Inc:Says results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options.Including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals.  Full Article

Gilead Sciences Inc submits NDA to U.S FDA for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV
Thursday, 6 Nov 2014 08:30am EST 

Gilead Sciences Inc:Has submitted New Drug Application (NDA) to U.S. FDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for treatment of HIV-1 infection in adults.Data submitted in NDA support use of regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment.If approved, E/C/F/TAF would be Gilead`s first single tablet regimen to contain TAF.  Full Article

Gilead Sciences Inc raises low end of prior FY 2014 net product sales guidance
Tuesday, 28 Oct 2014 04:06pm EDT 

Gilead Sciences Inc:Revises FY 2014 net product sales to $22 - $23 billion (previous range $21-$23 billion).  Full Article

European CHMP adopts positive opinion for Gilead Sciences Inc 's Harvoni (Ledipasvir/Sofosbuvir) for the treatment of Chronic Hepatitis C Infection in adults
Friday, 26 Sep 2014 07:18am EDT 

Gilead Sciences Inc:Says the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on its Marketing Authorization Application (MAA) for Harvoni.Harvoni, is an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.Says CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest.Says CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.Says CHMP positive opinion for Harvoni is supported by data from three Phase 3 studies (ION-1, ION-2 and ION-3).Says these studies evaluated 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.Says these studies included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.  Full Article

Gilead Sciences Inc's investigational Tenofovir Alafenamide (TAF)-based single tablet HIV Regimen meets 48-Week primary objective in two phase 3 studies
Wednesday, 24 Sep 2014 08:30am EDT 

Gilead Sciences Inc:Says two Phase 3 clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives.Studies demonstrated that single tablet regimen comprising elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), was non-inferior to Gilead`s Stribild based on proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy.In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild.  Full Article

Gilead Sciences Inc announces data from phase 2 study of Simtuzumab for previously untreated pancreatic cancer
Wednesday, 17 Sep 2014 06:00am EDT 

Gilead Sciences Inc:Says results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer.In the study, the addition of simtuzumab (200 mg or 700 mg) to gemcitabine did not significantly increase progression-free survival (PFS) compared to placebo plus gemcitabine.PFS was the primary endpoint of the study.Says randomized, double-blind, placebo-controlled Phase 2 trial, 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab (200 mg, n=76; 700 mg, n=79) or placebo (n=81) in cycles of 28 days.Median PFS for the simtuzumab 200 mg, simtuzumab 700 mg and placebo groups was 3.5 months, 3.7 months and 3.7 months, respectively.Says difference in PFS between the simtuzumab and placebo arms was not statistically significant.Says there was no difference in adverse events between patients taking simtuzumab versus placebo.  Full Article

Gilead Sciences Inc announces generic licensing agreements with Cadila Healthcare Ltd and others
Monday, 15 Sep 2014 06:30am EDT 

Gilead Sciences Inc:Says it has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries.Agreements allow the companies - Cadila Healthcare, Cipla , Hetero Labs ,Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab - to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible.The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities.The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.  Full Article

Exclusive: Express Scripts presses for expansion of drugs it won't cover

LOS ANGELES - Express Scripts, the largest manager of prescription drug plans for U.S. employers, is taking an increasingly aggressive stance in price negotiations with pharmaceutical companies after winning discounts on medications with a strategy introduced last year.

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