FBR Capital Remains on Sidelines with Intercept Pharmaceuticals (ICPT) Following FDA Panel Backing
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Rating Summary:
13 Buy, 17 Hold, 3 Sell
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Today's Overall Ratings:
Up: 13 | Down: 11 | New: 11
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FBR Capital analyst Vernon Bernardino reiterated a Market Perform rating and $192 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) after the FDA's Gastrointestinal (GI) Drugs Advisory Committee (GIDAC) supported accelerated approval of obeticholic acid (OCA) as a treatment for primary biliary cholangitis (PBC).
Bernardino commented, "Although the GIDAC panelists had general concerns about the validity of serum alkaline phosphatase (ALP) levels as a surrogate endpoint (SEP), they concluded that there was substantial evidence correlating a reduction in ALP with a meaningful positive effect on disease progression to death and/or liver transplantation in OCA-treated patients. The next steps likely involve discussions on specific post-marketing (Phase IV) confirmatory trial requirements and specific items to include in a proposed label prior to the FDA’s decision whether to approve Ocaliva (OCA’s provisional brand name), which is expected by the PDUFA date of May 29, 2016. We make minor changes in our model to incorporate insights gained from yesterday’s discussion, but as we view upside potential and downside risk in ICPT stock as evenly balanced, we remain at Market Perform."
For an analyst ratings summary and ratings history on Intercept Pharmaceuticals click here. For more ratings news on Intercept Pharmaceuticals click here.
Shares of Intercept Pharmaceuticals closed at $163.83 yesterday.
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