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 Type II variation application for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
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 theEuropean Union (EU).
The Type II variation application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and theUniversity of Washington, respectively. In studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen.
“The CHMP’s opinion moves the medical community closer to being able to offer an additional HIV prevention tool to people at high risk of HIV acquisition across the entire EU,” said Professor Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Parisand University of Paris 7. “Evidence supports pre-exposure prophylaxis, in combination with safer sex practices, to reduce the risk of sexually acquired HIV and we look forward to the potential public health impact of PrEP, in addition to increasing access to testing and universal treatment of people living with the disease, in helping to lower HIV transmission rates in Europe.” (Original Source)
Shares of Gilead Sciences closed yesterday at $87.24, up $0.58 or 0.67%. GILD has a 1-year high of $120.37 and a 1-year low of $77.92. The stock’s 50-day moving average is $84.56 and its 200-day moving average is $88.54.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on July 14, Jefferies Co. analyst Brian Abrahams reiterated a Hold rating on GILD, with a price target of $97, which represents a potential upside of 11.2% from where the stock is currently trading. Separately, on July 8, 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, Brian Abrahams and Jason Kolbert have a total average return of 5.3% and -15.8% respectively. Abrahams has a success rate of 59% and is ranked #597 out of 3996 analysts, while Kolbert has a success rate of 30% and is ranked #3995.
The street is mostly Bullish on GILD stock. Out of 13 analysts who cover the stock, 8 suggest a Buy rating and 5 recommend to Hold the stock. The 12-month average price target assigned to the stock is $112.00, which implies an upside of 28% from current levels.