ARTICLE | Product Development

Further delays at FDA for Intercept’s NASH therapy

May 23, 2020 1:32 AM UTC

Four months after Intercept disclosed FDA had pushed out the PDUFA date for its non-alcoholic steatohepatitis therapy to June 26, the company is now expecting a further delay in the agency’s review of obeticholic acid.

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) lost $11.18 (12%) to $80.51 Friday after announcing FDA postponed an advisory committee meeting for the oral farnesoid X receptor (FXR; NR1H4) agonist for a second time. The panel had already been rescheduled from April 22 to June 9 due to COVID-19. The company said FDA has indicated it will reach out in the near future with a new proposed meeting date...