Gilead Sciences, Inc. (NASDAQ:GILD) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency(EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). The data included in the application support the use of TAF in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at one-tenth the dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, TAF improved certain renal and bone laboratory safety parameters compared to TDF in clinical trials.
The 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, Norway and Iceland.
The MAA for TAF includes data from two international Phase 3 studies (Studies 108 and 110) in 1,298 treatment-naïve and treatment-experienced patients with HBV infection. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. The full data from Studies 108 and 110 were presented at the International Liver Congress™ (ILC) earlier this year.
TAF as a single-agent for HBV is an investigational product and its safety and efficacy have not yet been established.(Original Source)
Shares of Gilead Sciences are currently trading at $76.96, down %0.88 or -1.13%. GILD has a 1-year high of $108.63 and a 1-year low of $71.39. The stock’s 50-day moving average is $76.53 and its 200-day moving average is $81.77.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on November 7, Mizuho analyst Salim Syed initiated coverage with a Buy rating on GILD and a price target of $88, which represents a potential upside of 13% from where the stock is currently trading. Separately, on November 4, Maxim Group’s Jason Kolbert reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Salim Syed and Jason Kolbert have a yearly average return of 7.6% and a loss of 16.1% respectively. Syed has a success rate of 100% and is ranked #2173 out of 4200 analysts, while Kolbert has a success rate of 26% and is ranked #4076.
Sentiment on the Street is mostly bullish on GILD stock. Out of 16 analysts who cover the stock, 11 suggest a Buy rating and 5 recommend to Hold the stock. The 12-month average price target assigned to the stock is $99.00, which implies an upside of 27% from current levels.