Company Update (NASDAQ:GILD): Gilead Sciences, Inc. Submits New Drug Application to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir


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Gilead Sciences, Inc. (NASDAQ:GILD) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “SOF/VEL/VOX has the potential to fill that need by offering single tablet dosing and high cure rates across all HCV genotypes for patients with and without cirrhosis, who have failed prior treatment with other highly effective regimens.”

The NDA for SOF/VEL/VOX is based on data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A-containing regimen. Of the 445 patients treated with SOF/VEL/VOX, 430 (97 percent) achieved the primary efficacy endpoint of SVR12. The NDA is further supported by two additional Phase 3 studies (POLARIS-2 and POLARIS-3) in which 611 DAA-naïve HCV-infected patients received 8 weeks of SOF/VEL/VOX. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016. (Original Source)

Shares of Gilead are currently trading at $71.09, down $1.69 or -2.32%. GILD has a 1-year high of $104.79 and a 1-year low of $70.83. The stock’s 50-day moving average is $73.34 and its 200-day moving average is $80.81.

On the ratings front, GILD stock has been the subject of a number of recent research reports. In a report issued on December 6, Jefferies analyst Brian Abrahams reiterated a Buy rating on GILD, with a price target of $91, which represents a potential upside of 26% from where the stock is currently trading. Separately, on November 17, Leerink Swann’s Geoff Porges reiterated a Hold rating on the stock and has a price target of $89.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Geoff Porges have a yearly average loss of 2.0% and 6.1% respectively. Abrahams has a success rate of 41% and is ranked #3693 out of 4271 analysts, while Porges has a success rate of 14% and is ranked #3986.

Overall, 4 research analysts have assigned a Hold rating and 12 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 $92.00 which is 27.0% above where the stock opened today.

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 (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, oncology and inflammation, and serious cardiovascular and respiratory conditions.