The FDA stated that any resubmission would require successful completion of the long-term outcomes phase of the REGENERATE study.

Intercept has decided to discontinue all NASH-related investment and restructure its operations to focus on rare and serious liver diseases, aiming for profitability in 2024.

The company will reduce its workforce by approximately one-third and prioritize a fixed-dose combination of OCA and bezafibrate. 

Results showed that OCA 5-10 mg + bezafibrate 400 mg combo effectively normalized multiple biochemical markers associated with PBC-induced liver damage.

Biochemical remission, defined as normalization of associated biomarkers, was induced in 58% of patients on OCA5-10/B400 at 12 weeks vs. 7% (bezafibrate 200 mg), 27% (bezafibrate 400 mg), and 31% (OCA5-10/B200) in the other treatment arms. 

Further, patients in the OCA5-10/ bezafibrate 400 arm experienced consistently high levels of normalization of individual biomarkers. 

Patients in the OCA5-10/B400 arm demonstrated the highest reduction rates from baseline in biomarkers, with a clear dose-response in markers shown to predict transplant-free survival.

The company expects a net reduction in annual adjusted operating expenses of approximately $140 million – relative to the updated 2023.

Price Action: ICPT shares are up 4.76% at $12.10 during the premarket session on the last check Friday.