GSK showcases progress in liver portfolio at AASLD 2026

• Hibsago (bepirovirsen) treatment for patients with chronic hepatitis B (CHB) reinforced by new long-term dataset

• Further Hibsago research on surface antigen (HBsAg) reduction, retreatment modelling and functional cure predictors to inform future treatment strategies

• Latest efimosfermin phase II data highlight the potential for fibrosis improvement in patients with advanced metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis (F4)

• 21 abstracts reflect significant progress across CHB, MASH and alcohol-related liver disease (ALD) which account for the majority of liver-related deaths^1-4

GSK plc (LSE/NYSE: GSK) will present new data from its advancing liver portfolio at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2026, taking place in Denver, Colorado (5-9 November). These findings demonstrate significant progress across chronic hepatitis B (CHB), metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD), reinforcing GSK’s pipeline to improve patient outcomes across the spectrum of chronic liver disease.

Advancing Hibsago (bepirovirsen) as a foundational treatment for CHB

Following the recent US Food and Drug Administration (FDA) approval of Hibsago,⁵ a comprehensive long-term dataset at AASLD reinforces its benefit in CHB patients.

• B-Well phase III results will show functional cure rates 48 weeks after all chronic hepatitis B virus (HBV) treatment is stopped in virologically suppressed CHB patients (Oral presentation #0266).

• Data will be presented on surface antigen (HBsAg) reduction in participants who did not achieve functional cure a year after therapy was stopped, informing GSK’s continued research into the clinical significance of HBsAg reductions in patient outcomes (Poster presentation #4151).

• Additional B-Well analysis will be shared on HBsAg levels at week 12 and treatment completion as predictors of likelihood of functional cure, supporting identification of patients for treatment response (Oral presentation #0260).

• Predictive modelling will be presented on bepirovirsen retreatment and likelihood of functional cure in patients who relapse after an initial treatment course (Poster presentation #4163).

• Retrospective cohort analysis will be shared on HBsAg loss and the reduction in long-term risk of severe health outcomes, including cirrhosis and hepatocellular carcinoma, in CHB patients in China (Poster presentation #4045).

Investigating efimosfermin for fibrosis improvement in MASH

Latest data further support the potential of efimosfermin in patients with MASH, particularly those with advanced disease or at high-risk of disease progression who have limited or no approved treatment options.

• Phase II results will be presented on non-invasive markers of liver fibrosis across MASH patients with moderate to advanced fibrosis or compensated cirrhosis, supporting continued evaluation in phase III trials (Poster presentation #2299).

• Phase II analysis will be shared on the association between liver fat reduction and fibrosis in F2-F3 patients, reinforcing efimosfermin’s potential impact on key drivers of MASH progression (Poster presentation #5025).

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I), and Head of Translational & Development Sciences, GSK, said: “With liver diseases like CHB, MASH, and ALD causing around 2 million deaths globally each year, the urgent need for new treatments is clear. At AASLD, we’re sharing new data from our accelerating liver portfolio, demonstrating our ambition to drive new research and deliver transformative solutions for patients who currently face limited therapeutic options.”

Despite existing therapies, liver diseases represent a significant global disease burden, accounting for 1 in 25 deaths worldwide,⁶ with CHB, MASH and ALD comprising the majority of liver-related deaths.^1-4 Existing treatments for CHB can suppress the virus but many patients often require lifelong therapy.⁷ Treatments currently approved under accelerated or conditional pathways for MASH are indicated for moderate to advanced liver fibrosis; there are no approved treatment options for more advanced forms of MASH.⁸ Beyond medications that support alcohol abstinence, there are currently no approved medicines that directly address ALD.^9-10

Full list of GSK presentations at AASLD 2026

About chronic hepatitis B

Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B (CHB) occurs when the immune system is unable to clear the virus, resulting in long-lasting infection that affects over 240 million people worldwide. CHB causes approximately 1.1 million deaths each year¹¹ and is the leading cause of liver cancer cases globally.¹² Currently, many patients often require lifelong antiviral therapy for viral suppression, making functional cure a critical goal in disease management.

About MASH and ALD

Metabolic-dysfunction associated steatohepatitis (MASH) and alcohol-related liver disease (ALD) are chronic, progressive liver diseases where fibrosis (scarring) and inflammation can lead to major adverse liver outcomes (MALOs) including cirrhosis, liver cancer and liver failure. In MASH, the accumulation of fat and associated fibrosis is generally in response to metabolic dysregulation while in ALD, it is primarily alcohol related. MASH and ALD are each estimated to affect up to 5% of the global adult population and are two of the leading causes of liver transplants.^13-17

About Hibsago (bepirovirsen)

Bepirovirsen is an antisense oligonucleotide (ASO) designed to recognise and inhibit the production of the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control. Bepirovirsen reduces the production of RNA and viral proteins associated with HBV, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and may stimulate the immune system to increase the chances of a durable and sustained response.

GSK licensed bepirovirsen from Ionis and collaborated with them on its development. Bepirovirsen has been recognised by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Breakthrough Designation and priority review from the US FDA, Breakthrough Therapy and Priority Review designation in China and SENKU designation in Japan. Bepirovirsen is approved in Japan and the US.

For product and important safety information, please consult the full US Prescribing Information here.

About efimosfermin

Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate multiple metabolic pathways to decrease liver fat, ameliorate inflammation, and reverse liver fibrosis in MASH and ALD patients. Efimosfermin is advancing through clinical development across multiple potential indications, including in the ZENITH phase III trials for MASH with moderate to advanced fibrosis (F2-3), the NEBULA phase III trials for MASH with compensated cirrhosis (F4), and the ALLSTAR phase II trial for ALD.

Efimosfermin has received Breakthrough Therapy Designations from the US FDA and China’s CDE, as well as Priority Medicines (PRIME) Designation from the European Medicines Agency (EMA), for the treatment of MASH.

About GSK in hepatology

GSK is extending its expertise in hepatology to develop a next wave of innovation for the millions of people affected by chronic and life-threatening fibro-inflammatory liver conditions. GSK has a growing hepatology pipeline, harnessed by the science of the immune system and advanced technologies, with programmes focused on chronic hepatitis B (CHB), metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD). 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q3 Results for 2026.

References

1. Devarbhavi H, et al. Global Burden of Liver Disease: 2026 update. 2026. DOI: 10.1053/j.gastro.2026.09.014.

2. Xiao J, Wang F, Yuan Y, et al. Epidemiology of liver diseases: Global disease burden and forecasted research trends. Science China Life Sciences. 2024;68(2):541-557. DOI:10.1007/s11427-024-2722-2

3. Younossi ZM, Paik JM, Lazarus JV, et al. Projected Global Clinical, humanistic, and economic impact of metabolic dysfunction-associated steatohepatitis (MASH): The cost of inaction based on data from nine countries. Clinical Gastroenterology and Hepatology. 2026;24(4):1016-1034. DOI:10.1016/j.cgh.2025.09.002

4. Shen F, Li B, Lv H, et al. Global, regional, and national burden of chronic hepatitis B, 1990–2021, and projections to 2030: An urgent call for action to achieve hepatitis B elimination goals by 2030. Human Vaccines & Immunotherapeutics. 2026;22(1). DOI:10.1080/21645515.2026.2641857

5. GSK press release - Hibsago US approval. Available at: https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/.

6. Devarbhavi H, et al. J Hepatol. 2023;79(2):516–537

7. Gopalakrishna H, Ghany MG. Perspective on emerging therapies to achieve functional cure of chronic hepatitis B current Hepatology Reports. SpringerLink. February 10, 2024. Accessed October 2026.

8. Miller DM, McCauley KF, Dunham-Snary KJ. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): Mechanisms, Clinical Implications and Therapeutic Advances. Int J Mol Sci. 2024;25(10):5487. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12627968/. Last accessed: October 2026.

9. Zhang M, et al. Current Therapeutic Targets for Alcohol-Associated Liver Disease. American Journal of Pathology. 2026;196(1). DOI: 10.1016/j.ajpath.2025.06.009.

10. Queralt Herms, Jordi Gratacós-Ginès, Elisa Pose, Alcohol-related liver disease, Gastroenterology Report, Volume 13, 2025, goaf088, https://doi.org/10.1093/gastro/goaf088 .

11. WHO Global Hepatitis Report 2026. Available at: https://www.who.int/publications/i/item/9789240122383 (last accessed August 2026)

12. Rumgay H et al. Global burden of primary liver cancer in 2020 and predictions to 2040. J Hepatol. 2022;77:1598–1606. doi: 10.1016/j.jhep.2022.08.021

13. Åberg F, et al. Alcohol-associated liver disease-Global epidemiology. Hepatology. 2024;80(6):1307-1322. DOI: 10.1097/HEP.0000000000000899.

14. Niu X, et al. Global prevalence, incidence, and outcomes of alcohol related liver diseases: a systematic review and meta-analysis. BMC Public Health. 2023;23(1):859. DOI: 10.1186/s12889-023-15749-x.

15. Povsic M, et al. A Structured Literature Review of the Epidemiology and Disease Burden of Non-Alcoholic Steatohepatitis (NASH). Advances in Therapy. 2019;36(7):1574-94. DOI: 10.1007/s12325-019-00960-3.

16. Paklar N, Mijic M, Filipec-Kanizaj T. The Outcomes of Liver Transplantation in Severe Metabolic Dysfunction-Associated Steatotic Liver Disease Patients. Biomedicines. 2023 Nov 20;11(11):3096. DOI: 10.3390/biomedicines11113096.

17. Musto et al. Early Liver Transplant for Alcohol-associated Liver Disease Has Excellent Survival but Higher Rates of Harmful Alcohol Use. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1646-1656.e2. DOI: 10.1016/j.cgh.2024.04.025.