Q2 2026 Recap: Hepatology News & Updates

The second quarter of 2026 marked a pivotal period in hepatology, with historic regulatory milestones and promising late-stage clinical data accelerating progress in chronic viral liver diseases. From the first US Food and Drug Administration (FDA)-approved therapy for hepatitis delta to continued momentum toward a functional cure for hepatitis B, the quarter highlighted meaningful advances in areas of longstanding unmet need.

Among the quarter's most significant developments was the FDA approval of bulevirtide (Hepcludex), the first therapy approved in the US for chronic hepatitis delta virus infection. The FDA also granted Priority Review and Breakthrough Therapy designation to bepirovirsen for chronic hepatitis B, while pivotal phase 3 data demonstrated the investigational antisense oligonucleotide achieved a 19% functional cure rate, reinforcing its potential to transform HBV management.

Progress also continued across the viral hepatitis pipeline. Phase 2b results from the AZURE-1 trial demonstrated robust antiviral activity with the investigational monoclonal antibody brelovitug in chronic hepatitis delta, while regulatory momentum expanded beyond viral hepatitis with the FDA granting Priority Review to saroglitazar for primary biliary cholangitis (PBC).

In this Q2 hepatology review, the editorial team of HCPLive Hepatology recaps the quarter's most important regulatory decisions, clinical trial milestones, and therapeutic advances shaping the future of liver disease care.

FDA Grants Bepirovirsen Breakthrough Therapy Designation, Priority Review for Chronic Hepatitis B

On April 28, 2026, the FDA accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide developed by GSK in partnership with Ionis Pharmaceuticals, for the treatment of adults with chronic hepatitis B. The Agency simultaneously granted bepirovirsen Breakthrough Therapy designation and established a PDUFA target action date of October 26, 2026.

If approved, bepirovirsen would represent the first therapy to achieve clinically meaningful functional cure rates in this population, addressing a significant gap in the current treatment landscape.

AZURE-1: Brelovitug Meets Key Endpoints in Hepatitis D, With Tatyana Kushner, MD

On April 27, 2026, Mirum Pharmaceuticals announced that the primary endpoint was met in the phase 2b portion of the AZURE-1 study evaluating brelovitug, an investigational monoclonal antibody designed to bind hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus.

At week 24, treatment with brelovitug demonstrated robust antiviral activity across both dose groups. 100% of patients in the 300 mg once weekly (QW) arm and 75% of patients in the 900 mg once every 4 weeks arm achieved virologic response (≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA [<LLOQ, TND]), as compared to 0% in the delayed treatment arm.

Bulevirtide Receives Historic First FDA Approval for Chronic Hepatitis Delta

On May 22, 2026, the FDA approved bulevirtide (Hepcludex) injection for chronic HDV infection in adults without cirrhosis or with compensated cirrhosis, making it the first FDA-approved therapy for chronic HDV infection. The Agency granted approval of the first-in-class entry inhibitor to Gilead Sciences under the Accelerated Approval pathway based on MYR301, a multicenter, randomized, open-label, parallel-arm phase 3 trial.

Related: Liver Lineup: HDV Diagnosis, Bulevirtide, and the Delta Pipeline

FDA Grants Priority Review to Saroglitazar NDA for Primary Biliary Cholangitis

On May 28, 2026, the FDA granted Priority Review to Zydus Therapeutics’ new drug application (NDA) for saroglitazar in adults with PBC. The application seeks approval for use with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in those unable to tolerate UDCA. The FDA has also assigned a Prescription Drug User Fee Act target action date of November 27, 2026.

Related: Saroglitazar Targets Bile Acid Dysregulation, Inflammation in PBC, With Raj Vuppalanchi, MD

Bepirovirsen Achieves 19% Functional Cure in Chronic Hepatitis B

On May 28, 2026, GSK announced pivotal phase 3 data for bepirovirsen, an investigational antisense oligonucleotide, showing a statistically significant functional cure rate of 19% in adults with chronic hepatitis B. Results were simultaneously published in the New England Journal of Medicine and presented at the European Association for the Study of the Liver (EASL) congress.