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 tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvements in surrogate laboratory markers of renal and bone safety as compared to Viread.
“Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Given its lower dose, efficacy and safety profile, TAF has the potential to offer patients an improved treatment option that may advance their long-term care of chronic HBV.”
The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy compared to Gilead’s Viread among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, changes in renal and bone laboratory safety parameters favored the TAF regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving Viread. Additionally, the overall median change in serum creatinine from baseline to week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.
Gilead plans to submit a regulatory application for TAF in the European Union in the first quarter of 2016.
TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established. (Original Source)
Shares of Gilead Sciences closed yesterday at $96.50. GILD has a 1-year high of $123.37 and a 1-year low of $86. The stock’s 50-day moving average is $102.19 and its 200-day moving average is $106.77.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released yesterday, J.P. Morgan analyst Cory Kasimov reiterated a Buy rating on GILD, with a price target of $133, which represents a potential upside of 37.8% from where the stock is currently trading. Separately, on January 7, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $134.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Joshua Schimmer have a total average return of -12.2% and -14.7% respectively. Kasimov has a success rate of 23.4% and is ranked #3548 out of 3594 analysts, while Schimmer has a success rate of 20.8% and is ranked #3579.
The street is mostly Bullish on GILD stock. Out of 10 analysts who cover the stock, 9 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $125.80, which represents a potential upside of 30.4% from where the stock is currently trading.