ARTICLE | Product Development
Intercept plots resubmission in NASH based on new analysis, methodology
Two years after FDA setback, the biotech believes it has alignment with agency to seek accelerated approval
July 7, 2022 8:48 PM UTC
New Phase III data for Intercept’s obeticholic acid may suffice to support a long-awaited resubmission in NASH, but the readout hasn’t yet shown to be a value-driving catalyst for investors.
Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said a new analysis from the Phase III REGENERATE trial showed that the higher 25 mg dose of obeticholic acid (OCA) led to significant improvements in fibrosis without worsening of non-alcoholic steatohepatitis compared with placebo, meeting one of two co-primary endpoints (22.4% vs. 9.6%, p<0.0001)...