This segment focuses on the research, development, and commercialization of therapeutics for Primary Biliary Cholangitis (PBC), a chronic, progressive liver disease. The primary product in this segment is Ocaliva (obeticholic acid), a farnesoid X receptor (FXR) agonist. Research and development activities include clinical trials to evaluate Ocaliva's efficacy and safety in PBC patients, as well as exploring its potential in combination with other therapies. The company utilizes advanced pharmaceutical technologies and methodologies, including drug formulation, clinical trial design, and regulatory submissions. The patient impact is significant, as Ocaliva provides a treatment option for a disease with high unmet medical needs, improving liver function and potentially delaying disease progression. Market positioning is strong, with Ocaliva being a key product in the PBC treatment landscape. Future opportunities include expanding the use of Ocaliva and developing new therapies for PBC. Regulatory and clinical aspects involve ongoing interactions with regulatory agencies like the FDA and EMA, as well as conducting post-marketing studies to monitor long-term safety and efficacy. Partnerships and collaborations are essential for clinical trials and commercialization efforts.

This segment is dedicated to the research and development of therapies for Nonalcoholic Steatohepatitis (NASH), a progressive liver disease characterized by inflammation and liver damage. The company is actively involved in clinical trials to evaluate the efficacy and safety of Ocaliva in NASH patients. Research activities include identifying biomarkers, understanding disease mechanisms, and developing novel therapeutic approaches. The company employs advanced technologies and methodologies, including drug discovery, clinical trial design, and data analysis. The therapeutic area focuses on addressing the significant unmet medical need in NASH, aiming to reduce liver inflammation, fibrosis, and prevent disease progression. Market positioning is focused on becoming a leader in NASH treatment. Future opportunities include expanding the clinical development program and exploring combination therapies. Regulatory and clinical aspects involve interactions with regulatory agencies and conducting clinical trials to demonstrate safety and efficacy. Partnerships and collaborations are crucial for advancing research and development efforts in this area.