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 Vosevi®, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The 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, Norway and Iceland.
The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents. The single tablet regimen of sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®. The single tablet regimen of sofosbuvir (400 mg) and velpatasvir (100 mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa®.
Gilead has also submitted a regulatory application for SOF/VEL/VOX in the United States. Gilead filed the New Drug Application for SOF/VEL/VOX on December 8, 2016, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017.
SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established and is not approved anywhere globally.
Shares of Gilead Sciences closed yesterday at $70.48, up $2.98 or 4.41%. GILD has a 1-year high of $88.85 and a 1-year low of $63.76. The stock’s 50-day moving average is $65.53 and its 200-day moving average is $69.00.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released today, Deutsche Bank analyst Andrew Peters initiated coverage with a Buy rating on GILD and a price target of $79, which implies an upside of 12% from current levels. Separately, on June 14, William Blair’s John Sonnier reiterated a Buy 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, Andrew Peters and John Sonnier have a yearly average loss of 7.3% and a return of 20.3% respectively. Peters has a success rate of 45% and is ranked #4126 out of 4583 analysts, while Sonnier has a success rate of 59% and is ranked #336.
Sentiment on the street is mostly bullish on GILD stock. Out of 13 analysts who cover the stock, 11 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $83.71, which implies an upside of 19% from current levels.
Gilead Sciences, Inc. is a biopharmaceutical company, which discovers, develops and commercializes therapeutics for unmet medical need. It focuses on human immunodeficiency virus and liver diseases, such as chronic hepatitis C virus infection & chronic hepatitis B virus infection, hematology & oncology, and cardiovascular & inflammation as well as respiratory diseases. The company’s products include Descovy, Odefsey, Genvoya, Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost, Vitekta, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, Hepsera, Zydelig, Letairis, Ranexa, Lexiscan, Cayston, Tamiflu, AmBisome and Macugen.