Intercept's OCA is a leader in the NASH race, but the space is becoming increasingly crowded.
In its first-quarter release, Intercept announced that the enrollment of an interim cohort for its pivotal liver disease trial Regenerate is now complete, which sets up an interim read-out for the first half of 2019. While the company had recently scaled back its interim trial cohort to 750 from 1,400 patients after finalizing the definition of its primary endpoint, the news removes some uncertainty regarding the trial’s timeline. We do not expect to change our $205 per share fair value estimate...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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