Company Update (NASDAQ:GILD): Gilead Sciences, Inc. Announces EMA Validation of Marketing Authorization Application for Investigational Chronic


Gilead Sciences, Inc. (NASDAQ:GILD) announced that the company’s Marketing Authorization Application (MAA) for the 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 has been fully validated and is now under assessment by the European Medicines Agency (EMA).

“Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”

The MAA for SOF/VEL/VOX is supported by data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A inhibitor-containing regimen. Across the two studies, 97 percent of patients treated with SOF/VEL/VOX (n=430/445) achieved the primary efficacy endpoint of SVR12. The MAA also includes data from two additional phase 3 studies (POLARIS-2 and POLARIS-3), which evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with genotypes 1-6. 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 were headache, fatigue, diarrhea and nausea.

SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland. The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest. Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for SOF/VEL/VOX on December 8, 2016.

SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established. (Original Source)

Shares of Gilead Sciences closed yesterday at $71.57, down $0.56 or 0.78%. GILD has a 1-year high of $103.10 and a 1-year low of $70.83. The stock’s 50-day moving average is $73.62 and its 200-day moving average is $77.43.

On the ratings front, Gilead Sciences has been the subject of a number of recent research reports. In a report issued on January 18, Cowen analyst Phil Nadeau reiterated a Buy rating on GILD, with a price target of $100, which represents a potential upside of 40% from where the stock is currently trading. Separately, on January 12, Jefferies’ Brian Abrahams 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, Phil Nadeau and Brian Abrahams have a yearly average return of 1.8% and 2.7% respectively. Nadeau has a success rate of 45% and is ranked #1656 out of 4365 analysts, while Abrahams has a success rate of 46% and is ranked #1314.

Sentiment on the street is mostly bullish on GILD stock. Out of 15 analysts who cover the stock, 11 suggest a Buy rating and 4 recommend to Hold the stock. The 12-month average price target assigned to the stock is $84.50, which implies an upside of 18% from current levels.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Its primary areas of focus include primary areas of focus include human immunodeficiency virus, liver diseases such as chronic hepatitis C virus infection and chronic hepatitis B virus infection, oncology and inflammation, and serious cardiovascular and respiratory conditions.

 

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