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 Marketing Authorization Application (MAA) for the investigational, once-daily single tablet regimen Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg) for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naïve individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment.
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. If authorized, Genvoya would be Gilead’s first single tablet regimen to contain TAF.
TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents.
The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.
In addition to Genvoya, two other TAF-based regimens are currently under evaluation by the EMA. The first is an investigational, fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents. The second is an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies ofJohnson & Johnson.
TAF and all TAF-based regimens are investigational products and their safety and efficacy have not been established in the European Union. (Original Source)
Shares of Gilead Sciences closed yesterday at $102.51. 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 $108.67 and its 200-day moving average is $108.77.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on September 22, William Blair analyst John Sonnier reiterated a Buy rating on GILD. Separately, on September 21, Cowen’s Phil Nadeau 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, John Sonnier and Phil Nadeau have a total average return of 21.7% and 23.9% respectively. Sonnier has a success rate of 63.6% and is ranked #199 out of 3764 analysts, while Nadeau has a success rate of 54.1% and is ranked #129.
The street is mostly Bullish on GILD stock. Out of 12 analysts who cover the stock, 12 suggest a Buy rating . The 12-month average price target assigned to the stock is $127.57, which represents a potential upside of 24.4% from where the stock is currently trading.