OCA is well-positioned in the NASH pipeline, but the space is becoming increasingly crowded.
Intercept’s fourth-quarter results were slightly above our full-year expectations, thanks to Ocaliva’s solid ramp in the primary biliary cholangitis, or PBC, market. However, the main driver for the firm continues to be its prospects in the NASH market. There were no major updates to the phase III Regenerate trial timeline or design in the earnings call. Earlier this month, we released a note detailing Intercept’s updates to its clinical trial design and NASH resolution definition. The firm look...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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