Gilead Sciences, Inc. (NASDAQ:GILD) today 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 two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents.
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). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
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.
The MAA for Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. In the studies, the F/TAF-based regimen demonstrated statistically significant improvements in surrogate laboratory markers of renal and bone safety as compared to the F/TDF-based regimen. The MAA is also supported by data from an additional Phase 3 study evaluating Descovy among virologically suppressed adults who switched regimens (Study 1089), and studies evaluating the F/TAF-based regimen (administered as Genvoya) among adults with mild-to-moderate renal impairment and among adolescents. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of Descovy achieved the same drug levels of TAF and emtricitabine in the blood as in Genvoya.
Descovy is an investigational product and its efficacy and safety have yet not been established in the European Union. (Original Source)
Shares of Gilead Sciences closed yesterday at $90.16, up $0.80 or 0.90%. GILD has a 1-year high of $123.37 and a 1-year low of $81.89. The stock’s 50-day moving average is $89.52 and its 200-day moving average is $100.90.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released yesterday, Citigroup analyst Yaron Werber initiated coverage with a Buy rating on GILD and a price target of $110, which represents a potential upside of 22.0% from where the stock is currently trading. Separately, on the same day, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $114.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yaron Werber and Joshua Schimmer have a total average return of 16.1% and -23.8% respectively. Werber has a success rate of 67.7% and is ranked #132 out of 3675 analysts, while Schimmer has a success rate of 16.7% and is ranked #3673.
Overall, 2 research analysts have assigned a Hold rating and 16 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $110.38 which is 22.4% above where the stock closed yesterday.