FBR Affirms Intercept Pharma (ICPT) at 'Market Perform'; Upside/Downside Balanced Amid Phase 3 POISE Publication
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FBR & Co. affirms Intercept Pharma (Nasdaq: ICPT) with a Market Perform rating and $200 price target after the company announced that the New England Journal of Medicine published the key results of the Phase 3 POISE trial of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis, formerly known as primary biliary cirrhosis (PBC).
We think POISE’s publication in the NEJM could help educate healthcare providers and validate OCA as a new treatment option for PBC. We believe that upside potential and downside risk are evenly balanced in ICPT stock.
Analyses of POISE results presented in the NEJM publication include data on OCA’s effects on markers of inflammation and liver damage, as well as non-invasive measures of fibrosis. Due to the modest duration of the study (12 months), POISE was not designed to assess OCA's effects on fibrosis. Thus, although positive changes in markers of inflammation and liver damage were observed, a change in fibrosis was not expected. Notably, the levels of cleaved cytokeratin 18 (cCK18), a marker of liver cell death, decreased significantly from baseline with OCA treatment versus placebo (p<0.0001), pointing to decreased liver damage.
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