Gilead Sciences, Inc. (NASDAQ:GILD) announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.
“Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”
The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Ninety-four percent of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83 percent and 86 percent of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2015, and were also published in The New England Journal of Medicine.
Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea.
SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive 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.
SOF/VEL is an investigational product and its safety and efficacy has not yet been established. (Original Source)
Shares of Gilead Sciences closed yesterday at $101.38, down $3.06 or -2.93%. GILD has a 1-year high of $123.37 and a 1-year low of $85.95. The stock’s 50-day moving average is $106.37 and its 200-day moving average is $109.78.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on November 30, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GILD, with a price target of $134, which represents a potential upside of 32.2% from where the stock is currently trading. Separately, on November 18, Needham’s Alan Carr reiterated a Buy rating on the stock and has a price target of $125.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Alan Carr have a total average return of -1.8% and 26.1% respectively. Schimmer has a success rate of 36.4% and is ranked #3112 out of 3631 analysts, while Carr has a success rate of 60.3% and is ranked #16.
The street is mostly Bullish on GILD stock. Out of 11 analysts who cover the stock, 9 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $128.33, which represents a potential upside of 26.6% from where the stock is currently trading.