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 fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.
“As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”
The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from 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. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent, while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.
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 were headache, fatigue and nausea. The most common adverse events in ASTRAL-4 were fatigue, nausea and headache.
Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year.
The SOF/VEL fixed-dose combination is an investigational product and its safety and efficacy have not been established. (Original Source)
Shares of Gilead Sciences closed today at $108.13, down $2.83 or 2.55%. 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 $103.41 and its 200-day moving average is $109.14.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released today, Oppenheimer analyst Wendy Lam reiterated a Buy rating on GILD, with a price target of $124, which implies an upside of 14.7% from current levels. Separately, on the same day, Cowen’s Phil Nadeau reiterated a Buy rating on the stock and has a price target of $130.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Wendy Lam and Phil Nadeau have a total average return of 3.5% and 15.1% respectively. Lam has a success rate of 75.0% and is ranked #2227 out of 3804 analysts, while Nadeau has a success rate of 57.7% and is ranked #255.
The street is mostly Bullish on GILD stock. Out of 12 analysts who cover the stock, 10 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $130.60, which implies an upside of 20.8% from current levels.