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 Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.
The CHMP positive opinion was adopted following an accelerated review 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 theEuropean Union, Norway and Iceland.
The MAA for Epclusa is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).
Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively). The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in theEuropean Union on November 18, 2014, under the trade name Harvoni®.
Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.
Epclusa is an investigational product and its safety and efficacy has not yet been established. (Original Source)
Shares of Gilead Sciences closed yesterday at $85.29, down $1.22 or -1.41%. GILD has a 1-year high of $123.37 and a 1-year low of $81.28. The stock’s 50-day moving average is $91.09 and its 200-day moving average is $93.94.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released yesterday, Morgan Stanley analyst Matthew Harrison maintained a Hold rating on GILD, with a price target of $103, which represents a potential upside of 20.8% from where the stock is currently trading. Separately, on May 24, Leerink Swann’s Geoff Porges 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, Matthew Harrison and Geoff Porges have a total average return of 4.4% and 0.3% respectively. Harrison has a success rate of 55.8% and is ranked #1025 out of 3869 analysts, while Porges has a success rate of 47.2% and is ranked #2232.
Overall, 5 research analysts have assigned a Hold rating and 10 research analysts have given a Buy rating on the stock. When considering if perhaps the stock is under or overvalued, the average price target is $108.43 which is 27% above where the stock closed yesterday.