Expect Slower PBC Sales After FDA Warning, No Read-Through to NASH; Lowering Intercept FVE to $188
Intercept tumbled 25% on Sept. 21 after the Food and Drug Administration gave a warning similar to what the company issued last week but also revealed that 19 deaths and 11 severe liver injuries were reported in patients taking liver drug Ocaliva in primary biliary cholangitis, a progressive liver disease. We plan to lower our fair value estimate to $188 per share from $205 to account for slower uptake in PBC and later in primary sclerosing cholangitis (currently being tested in clinical trials)...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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