GNFT - Intercept Pharmaceuticals: Regulatory Snub Unsettles Liver Therapy Front-Runner
Investment Thesis
Formulating the launch plans well ahead of the approval, Intercept Pharmaceuticals, Inc. (ICPT) caught completely off guard when the FDA refused to sign off OCA, a Intercept’s candidate for liver fibrosis in NASH. The agency, however, hasn’t completely shut the door on the company, encouraging it to make another attempt with a comprehensive set of data from the ongoing clinical outcome study. However, the loss-making company chasing a market opportunity worth billions of dollars in NASH therapeutics needs fresh capital to fund the late-stage studies as the rival candidates challenge the