Last Thursday, Gilead Sciences, Inc. (NASDAQ:GILD) announced Phase III POLARIS topline data with sofosbuvir (nucleotide polymerase inhibitor)/velpatasvir (NS5A inhibitor)/voxilaprevir (protease inhibitor) in treatment-naïve and treatment-experienced HCV patients. On the heels of the results, the biotech firm now intends to file a NDA with the FDA by the close of 2016, with plans to file in Europe soon after.
Additionally, GILD released updated Phase II trial results with selonsertib (GS-4779), an ASK-1 inhibitor, which targets the inflammatory component of nonalcoholic steatohepatitis (NASH), in combination with simtuzumab, a LOXL2 inhibitor, which targets the fibrotic element of NASH.
In reaction, William Blair analyst John Sonnier reiterates an Outperform rating on shares of GILD without suggesting a price target.
Considering GILD’S Phase III POLARIS program, the analyst anticipates that the triplet pangenotypic regimen will be used for 12 weeks as a “salvage therapy” for treatment-experienced HCV patients.
Sonnier opines, “Given the high efficacy (greater than 95% cure rate) of approved direct-acting antivirals in the HCV space, we view the salvage market as a marginally incremental opportunity for Gilead. However, given the severe unmet medical need and the extremely difficult-to-treat population, we see little competitive threat in the near term.”
Though the trial enrolled a limited size in patient population, the analyst notes he nonetheless remains “encouraged” by selonsertib’s safety as well as its efficacy when pointing to “the observed dose-response and the benign safety profile, especially in the context of combinability with other agents.”
However, Sonnier expresses less optimism with regards to the drug in context of NASH when considering GILD’S assessment that selonsertib combined with simtuzumab yielded a “roughly in line” performance with selonsertib monotherapy.
“Overall, we believe Thursday’s data release is an incremental positive to the stock, given the increased potential of revenue contribution from NASH and the triple combination in the salvage HCV setting,” the analyst concludes.
Moving forward, Sonnier has his eyes peeled to the full data release forthcoming in November’s American Association for the Study of Liver Diseases (AASLD) meeting in Boston, Massachusetts.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, four-star analyst John Sonnier is ranked #608 out of 4,190 analysts. Sonnier has a 44% success rate and earns 8.5% in his annual returns. When recommending GILD, Sonnier gains 5.3% in average profits on the stock.
TipRanks analytics exhibit GILD as a Buy. Based on 16 analysts polled in the last 3 months, 50% reiterate a Buy on GILD while 50% maintain a Hold. The 12-month average price target stands at $101.32, marking a nearly 37% upside from where the shares last closed.