Wedbush analyst Liana Moussatos weighed in today with a few insights on Intercept Pharmaceuticals Inc (NASDAQ:ICPT), after the company announced the design of its upcoming phase 3 trial for obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. Based on the company’s Phase 2 FLINT trial in NASH, the analyst believes the Phase 3 is achievable for OCA but Barrier for competition.
Moussatos noted, “We believe the positive results from FLINT reduce clinical risk for OCA in the Phase 3 NASH trial. The Phase 3 trial is expected to initiate in Q3:15. As we expected, a cardiovascular outcome trial (CVOT) will not be needed for accelerated approval. Management noted that patient lipid profile will be aggressively monitored and the initiation of statins will occur as necessary.”
Furthermore, “We believe the co-primary endpoints of NASH resolution and fibrosis improvement are likely to make it difficult for companies’ with product candidates that have yet to show an improvement in liver fibrosis get approval. Additionally, we believe that the large trial size serves as barrier for approval for other companies seeking approval of product candidates in NASH.”
The analyst reiterated an Outperform rating on shares of Intercept Pharmaceuticals Inc, while no price target was provided.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Liana Moussatos has a total average return of 40.8% and a 57.8% success rate. Moussatos has a 106.3% average return when recommending ICPT, and is ranked #14 out of 3606 analysts.