5 Hepatology Headlines You Missed in January 2026

January 2026 opened with major momentum across hepatology, particularly in metabolic and viral liver disease. The US Food and Drug Administration (FDA)’s decision to grant Breakthrough Therapy Designation to pemvidutide marked a significant milestone for metabolic dysfunction-associated steatohepatitis (MASH), reflecting growing confidence in dual agonist strategies supported by robust histologic and noninvasive data. In parallel, long-awaited phase 3 results for bepirovirsen signaled meaningful progress toward functional cure in chronic hepatitis B, with consistent efficacy across a broad, global patient population and especially strong responses in patients with lower baseline HBsAg levels.

Beyond late-stage trial readouts, January’s updates emphasized the evolving complexity of chronic liver disease care. Expert discussions highlighted the importance of addressing stigma and integrating multidisciplinary approaches in alcohol-associated liver disease, while advances in second-line therapies continued to reshape expectations for patients with primary biliary cholangitis (PBC). Rounding out the month, forward-looking perspectives on the MASH pipeline underscored a field transitioning from uncertainty to cautious optimism as multiple novel agents advance toward clinical reality.

Check out this January 2026 hepatology month in review for a recap of HCPLive’s coverage of the top hepatic news and research from the past few weeks:

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.

Addressing Stigma and Advancing Care in Alcohol-Associated Liver Disease, With Frances Lee, MD

Alcohol-associated liver disease remains a major and growing cause of liver-related morbidity and mortality, yet it is often approached through an oversimplified and stigmatized lens.

Misconceptions about who develops the disease, why it occurs, and how it should be treated continue to influence both patient engagement and clinical decision-making. With evolving understanding of the disease, Frances Lee, MD, describes increasing recognition that effective care extends beyond managing liver injury alone and requires a more nuanced, multidisciplinary approach.

Closing Gaps in PBC Care With Emerging and Established Second-Line Treatments

The therapeutic landscape for PBC has undergone a meaningful transformation in recent years, offering new optimism for a disease long defined by limited treatment options. A. Sidney Barritt, MD, and Frances Lee, MD, review recent therapeutic progress, ongoing challenges, and what they foresee for the future of PBC management.

MASH Pipeline Developments and Emerging Therapies to Watch in 2026, With Mazen Noureddin, MD, MHSc

After years of setbacks and uncertainty, the therapeutic landscape for MASH has entered a decisive new phase. Once characterized by failed trials and a lack of approved therapies, the field has rapidly shifted toward cautious optimism, driven by regulatory clarity, advancing endpoints, and a deepening late-stage pipeline.

Mazen Noureddin, MD, MHSc, recaps recent progress in MASH therapeutic development and looks ahead to what 2026 and beyond may offer.