Neutral Outlook on Intercept's NASH Trial Updates; $245 Fair Value Estimate Reaffirmed
Intercept announced two key changes to its phase III Regenerate trial evaluating obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH). We are neutral on the news and do not plan on changing our $245 fair value estimate, which assumes Intercept meets its 2019 interim data timeline and completes enrollment by mid-2017. While the clinical trial updates set a lower bar for FDA approval, the timeline for interim results and NDA submission in NASH remains unchanged. We also ...Intercept Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat progressive non-viral liver diseases. The company's marketed product, Ocaliva? (obeticholic acid or OCA), is an farnesoid X receptor agonist approved in the U.S., the European Union and several other jurisdictions for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. In addition to, the company is developing OCA for multiple indications, including nonalcoholic steatohepatitis.
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