Q1 2026 Recap: Hepatology News and Updates

The first quarter of 2026 brought a wave of momentum in hepatology, with advances spanning metabolic liver disease, viral hepatitis, rare genetic disorders, and symptom-directed care. From regulatory designations to late-stage clinical data and US Food and Drug Administration (FDA) approvals, the landscape continues to evolve rapidly, with a growing emphasis on disease modification and precision-based approaches.

Much of the quarter’s progress centered on MASH and hepatitis B, where emerging therapies are pushing the field closer to long-sought goals such as fibrosis improvement and functional cure. At the same time, gene-editing strategies for alpha-1 antitrypsin deficiency (AATD) highlighted the potential for one-time, durable treatments targeting the root cause of liver disease.

The quarter also featured meaningful strides in patient care, including the FDA approval of linerixibat as the first treatment for cholestatic pruritus in PBC and ongoing efforts to address complex conditions like hepatitis D. Alongside these innovations, expert discussions on nutrition, alcohol, and liver health reinforced the importance of holistic, multidisciplinary management.

Here’s a look at the key hepatology developments from Q1 2026:

Pemvidutide Gets Breakthrough Therapy Designation for MASH

On January 5, 2026, the FDA granted Breakthrough Therapy Designation to pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of patients with MASH. The decision was supported by 24-week data from the IMPACT phase 2b trial demonstrating statistically significant MASH resolution without worsening of fibrosis, along with early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation.

Bepirovirsen Meets Function Cure Endpoint in Phase 3 B-Well Trials for Hepatitis B

On January 7, 2026, GSK announced positive results from a pair of phase 3 trials, B-Well 1 and B-Well 2, evaluating bepirovirsen, an investigational antisense oligonucleotide, for the treatment of chronic hepatitis B in > 1800 patients from 29 countries. Both trials met their primary endpoint and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Of note, results were statistically significant across all ranked endpoints, including in patients with HBsAg <=1000 IU/ml where an even greater effect was demonstrated.

TSRA-196 Gets FDA Fast Track, Orphan Drug Designations for AATD

On February 23, 2026, the FDA granted Fast Track and Orphan Drug designations to TSRA-196, an in vivo gene editing program from Tessera Therapeutics, for the treatment of adults with AATD who are homozygous for the PiZ allele (PiZZ). TSRA-196 is being jointly developed with Regeneron and is designed to precisely correct the genetic mutation underlying AATD, with the goal of restoring production of functional AAT protein through a one-time, durable treatment option for patients.

Single Dose YOLT-202 Gene-Editing Therapy Increases Functional AAT Levels in AATD

On February 19, 2026, YolTech Therapeutics announced positive interim data from an investigator-initiated trial (IIT) of YOLT-202, the Company’s investigational in vivo base editing therapy, for the treatment of AATD. Findings demonstrated positive safety and tolerability as well as meaningful increases in AAT levels in evaluated patients treated with the 35 mg and 45 mg dose levels.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

On February 19, 2026, Devonian Health Group announced positive results from a follow-up preclinical study evaluating Thykamine™ in a human MASH model using PhysioMimix® Liver-on-a-Chip platform. Findings suggest Thykamine exerts dose-dependent effects on key pathological hallmarks of MASH, including fibrosis and inflammation, in a physiologically relevant human liver system, representing a notable translational bridge between Devonian’s previously disclosed efficacy in the mouse STAM® MASH model and a predictive human microphysiological model.

Liver Lineup: Nutrition, Alcohol, and Liver Health in the New Dietary Guidelines

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by 2 experts from their respective institutions to unpack the implications of the US Dietary Guidelines and what they mean for patients with liver disease. Amanda Van Jacobs, MS, RDN, a transplant dietitian at Rush University Medical Center, and Jessica Mellinger, MD, a transplant hepatologist at Henry Ford Health specializing in alcohol-associated liver disease, offer a nuanced, clinically grounded discussion that moves beyond headlines to practical patient care.

FDA Approves Linerixibat (Lynavoy) As First Treatment for Cholestatic Pruritus in PBC

On March 19, 2026, the FDA approved GSK’s linerixibat (Lynavoy) for the treatment of cholestatic pruritus in adult patients with PBC, making it the first medicine approved in the US for this indication. The decision was based on data from the global phase 3 GLISTEN trial, which met both primary and key secondary endpoints, demonstrating significant, rapid and sustained improvements in cholestatic pruritus and itch-related sleep interference versus placebo.

Inside the AZURE Program of Brelovitug for Hepatitis D, With Tatyana Kushner, MD

For clinicians managing hepatitis D virus (HDV) infection, the stakes are uniquely high. Unlike many other chronic viral hepatitides, HDV is widely recognized as the most aggressive form of viral hepatitis, often leading to rapid disease progression and severe long-term complications. Tatyana Kushner, MD, discusses brelovitug’s potential for the treatment of HDV and what will be learned from the phase 3 AZURE program.