Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nasdaq  >  Gilead Sciences    GILD

News SummaryMost relevantAll newsSector newsTweets 
The feature you requested does not exist. However, we suggest the following feature:

Gilead Sciences : Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir...

share with twitter share with LinkedIn share with facebook
share via e-mail
06/22/2017 | 09:12pm CEST

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

By a News Reporter-Staff News Editor at AIDS Weekly -- Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens (see also Drugs and Therapies - Antiretrovirals).

"We aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "This regulatory filing is a demonstration of Gilead's ongoing commitment to bringing forward treatment innovations that have the potential to address the needs of patients and physicians."

The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg) among treatment-naive patients and among virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing antiretroviral regimen with dolutegravir. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.

Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Keywords for this news article include: Antiinfectives, Antivirals, Pharmaceutical Companies, Genetics, HIV/AIDS, Tenofovir, RNA Viruses, Retroviridae, Emtricitabine, Vertebrate Viruses, Regulatory Agencies, Gilead Sciences Inc., Primate Lentiviruses, Drugs and Therapies - Antiretrovirals, Immune System Diseases and Conditions.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC

(c) 2017 NewsRx LLC, source Health Newsletters

share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on GILEAD SCIENCES
06/22 GILEAD SCIENCES : Submits New Drug Application to U.S. Food and Drug Administrat..
06/22 GILEAD SCIENCES : Patent Issued for Methods for Preparing Anti-Viral Nucleotide ..
06/21 GILEAD SCIENCES : Biotech Industry Showing Signs of a Revival in 2017: Today's R..
06/19 GILEAD SCIENCES : Receives Approval in Canada for VEMLIDY™ (Tenofovir Alaf..
06/16 GILEAD SCIENCES : submits drug application to FDA for HIV treatment
06/15 GILEAD SCIENCES : New Antibiotics Study Findings Have Been Reported by Researche..
06/15 GILEAD SCIENCES : CONTRACT AWARD - 65-- Bristo-Myers Squibb & Gilead Sciences, L..
06/15 GILEAD SCIENCES : submits drug application to FDA for HIV treatment
06/15 GILEAD SCIENCES : Stock Needs to Conquer These Hurdles
06/14 GILEAD SCIENCES, INC. : ex-dividend day
More news
Sector news : Bio Therapeutic Drugs
06/20 Novartis eye drug works with fewer injections than rival
06/15DJACTELION : J&J Maps Research Plans for Actelion -- WSJ
06/14DJACTELION : Correction to J&J Actelion Story
06/14DJACTELION : J&J Plans to Add Drug Discovery and Early Research to Actelion Unit
06/14 JOHNSON & JOHNSON : flu drug succeeds in mid-stage trial
More sector news : Bio Therapeutic Drugs
News from SeekingAlpha
06/22 Drug stocks rally on GOP draft of healthcare bill
06/22 GILEAD : The Conundrum
06/21 Biotechs blaze as Trump draft order on drug prices would ease regulations
06/21 Biotechs ripping, IBB up almost 8% in three days
06/20 DIVGRO PULSE : June 2017
Financials ($)
Sales 2017 24 660 M
EBIT 2017 15 036 M
Net income 2017 9 722 M
Debt 2017 4 528 M
Yield 2017 3,12%
P/E ratio 2017 9,11
P/E ratio 2018 10,05
EV / Sales 2017 3,76x
EV / Sales 2018 4,20x
Capitalization 88 204 M
More Financials
Duration : Period :
Gilead Sciences Technical Analysis Chart | GILD | US3755581036 | 4-Traders
Full-screen chart
Technical analysis trends GILEAD SCIENCES
Short TermMid-TermLong Term
Technical analysis
Income Statement Evolution
More Financials
Mean consensus OUTPERFORM
Number of Analysts 27
Average target price 77,6 $
Spread / Average Target 15%
Consensus details
EPS Revisions
More Estimates Revisions
John F. Milligan President, Chief Executive Officer & Director
John C. Martin Executive Chairman
Kevin B. Young Chief Operating Officer
Robin L. Washington Chief Financial Officer & Executive Vice President
Norbert W. Bischofberger Chief Scientific Officer & Executive VP-Research
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
AMGEN17.19%122 290
ACTELION23.58%30 377
More Results