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5 Hepatology Headlines You Missed in September 2025
Read about hepatic FDA news, the voluntary withdrawal of obeticholic acid for PBC, new trial data for a potential AATD drug, and more.
September 2025 delivered several important developments in hepatology, spanning US Food and Drug Administration (FDA) news, clinical trial data, and expert insights on recent progress in the field.
In the past month, the FDA accepted Echosens’ Letter of Intent for the qualification of Liver Stiffness Measurement (LSM) by Vibration-Controlled Transient Elastography (VCTE; FibroScan) as a reasonably likely surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH) and requested Intercept Pharmaceuticals withdraw obeticholic acid (Ocaliva) from the US market for the treatment of primary biliary cholangitis (PBC).
Paired with new trial data for a potential alpha-1 antitrypsin deficiency (AATD) drug, the release of the latest episode of Liver Lineup on recent developments in cholestatic disease, and expert insight on the overlap between liver and heart health, September was a busy month in hepatology.
Check out this September 2025 hepatology month in review for a recap of HCPLive’s coverage of the top hepatic news and research from the past few weeks:
FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials
On September 8, 2025, the FDA’s Center for Drug Evaluation and Research, Office of New Drugs accepted Echosens’ Letter of Intent for the qualification of LSM by VCTE (FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH. As stated in the Letter of Intent, which included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk, LSM by VCTE can predict the risk of all-cause mortality or liver-related events in patients with MASH.
Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market
On September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid (Ocaliva) from the US market for the treatment of PBC following a request from the FDA, The Agency additionally placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.
Liver Lineup: Innovations in Cholestatic Disease Management, With Kris Kowdley, MD
On the latest episode of Liver Lineup, host Nancy Reau, MD, is joined by Kris Kowdley, MD, to discuss evolving approaches in cholestatic liver disease, with a particular focus on PBC.
RestorAATion-2: WVE-006 Achieves Durable Serum AAT Protein Production in AATD
On September 3, 2025, Wave Life Sciences announced positive data from the 200 mg single and multidose and 400 mg single dose cohorts of the ongoing phase 1b/2a RestorAATion-2 study evaluating WVE-006 as a treatment for AATD. Study data showed WVE-006 achieved durable production of serum AAT protein at levels associated with a reduced risk of AATD liver and lung diseases following repeat 200 mg doses. While data from the 400 mg multidose cohort are not expected until 1Q 2026, single dose 400 mg data showed achievement of 12.8 µM total AAT and 5.3 µM M-AAT.
Addressing Cardiovascular Health in MASH, with Viet Le, DMSc, PA-C
Following the 2025 Gastroenterology & Hepatology Advanced Practice Providers (GHAPP) conference, the editorial team of HCPLive Gastroenterology sat down with Viet Le, DMSc, PA-C, to discuss his session on tackling this dual burden of cardiovascular disease and MASH.
