Published on 26 Jun 2023 on Zacks via Yahoo Finance
Intercept Pharmaceuticals, Inc. ICPT announced a restructuring program in the wake of the recent complete response letter (CRL) issued by the FDA to its new drug application (NDA) seeking approval for obeticholic acid (OCA) for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
Intercept will discontinue all NASH-related investments and immediately begin the process of closing out the REGENERATE study. Intercept expects to substantially complete the trial shut-down process by the end of 2023.
Apart from closing out REGENERATE, Intercept is also terminating all other NASH-related spending within its R&D, commercial, medical affairs and administrative functions.