Gilead Sciences Says EMA Will Consider Marketing Application For Hepatitis C Treatment

Gilead Sciences (GILD) Friday said its marketing authorization for an investigational combination of sofosbuvir, and velpatasvir, for the treatment of chronic hepatitis C virus infection, has been fully validated and is under assessment by the European Medicines Agency. . Gilread said the data included in the application, which was submitted on Nov. 17, support the use of the drugs for patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis. The marketing authorization for sofosbuvir and velpatasvir (SOF/VEL) is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Gilread said that SOF/VEL is its third investigational medicinal product for HCV infection to undergo accelerated assessment by the EMA. This, however, does not assure a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. Review of the MAA will be conducted under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. If approved, SOF/VEL could be available for marketing in the European Union in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the United States. GILD was slightly higher in recent pre-market trade.
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The stock is up 0.53% or $0.54 after the news, hitting $101.92 per share. About 2,003 shares traded hands. Gilead Sciences, Inc. (NASDAQ:GILD) has declined 3.46% since May 1, 2015 and is downtrending. It has underperformed by 0.67% the S&P500.

Out of 15 analysts covering Gilead Sciences (NASDAQ:GILD), 14 rate it “Buy”, 1 “Sell”, while 4 “Hold”. This means 74% are positive. Gilead Sciences was the topic in 20 analyst reports since July 29, 2015 according to StockzIntelligence Inc.
More notable recent Gilead Sciences, Inc. (NASDAQ:GILD) news were published by: Bidnessetc.com which released: “Gilead Sciences, Inc: Can the Senate Report Trigger Policy Changes?” on December 03, 2015, also Bidnessetc.com with their article: “Did Gilead Sciences, Inc. build its HCV Empire by Ripping Off Payers?” published on December 02, 2015, Fool.com published: “Better Dividend Stock: Gilead Sciences Inc. vs. Teva Pharmaceutical Industries” on November 16, 2015. More interesting news about Gilead Sciences, Inc. (NASDAQ:GILD) were released by: Fool.com and their article: “Gilead Sciences Inc. Has Plenty of Room to Run in Hepatitis C” published on November 21, 2015 as well as Seekingalpha.com‘s news article titled: “Gilead Sciences Stock Forecast For 2016” with publication date: November 26, 2015.
Gilead Sciences, Inc. , is a research biopharmaceutical firm that discovers, develops and commercializes innovative medicines. The company has a market cap of $146.11 billion. The Company’s primary areas of focus include human immunodeficiency virus (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, oncology and inflammation, and serious cardiovascular and respiratory conditions. It has 9.29 P/E ratio. The Company’s HIV products include Stribild, Complera/Eviplera, Atripla, Truvada, Viread, Emtriva, Tybost and Vitekta.