5 Hepatology Headlines You Missed in May 2026

May was a landmark month in hepatology, bringing major regulatory milestones, promising late-stage clinical data, and continued innovation in the diagnosis and management of chronic liver diseases. From historic progress in viral hepatitis to advances in cholestatic liver disease and emerging diagnostic technologies, the month underscored the rapid evolution of care across the specialty.

Among the most significant developments was the approval of bulevirtide (Hepcludex) by the US Food and Drug Administration (FDA) as the first-ever approved therapy for chronic hepatitis delta virus (HDV) infection, marking a historic milestone for patients with one of the most severe forms of viral hepatitis. Regulatory momentum also continued in primary biliary cholangitis (PBC), with the FDA granting Priority Review to the NDA for saroglitazar, while pivotal phase 3 data for bepirovirsen demonstrated a 19% functional cure rate in chronic hepatitis B, further advancing the pursuit of finite therapies for the disease.

Beyond viral hepatitis, progress continued in cholestatic liver diseases. New phase 2b data showed the investigational ileal bile acid transporter inhibitor volixibat significantly improved pruritus in patients with primary sclerosing cholangitis (PSC), while new diagnostic tools aimed at improving chronic liver disease detection and management entered clinical practice.

In this hepatology month in review, we highlight the key approvals, clinical trial results, and innovations that shaped May.

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.

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.

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 (ASO), 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.

Roche Launches Liver Disease Panel, An Algorithm-Based Tool for Identifying and Managing CLD

On May 26, 2026, Roche announced the launch of its comprehensive Liver Disease Panel, a suite of certified algorithms designed to help clinicians better identify and manage chronic liver disease. The tool brings together biomarker-based diagnostics and advanced digital algorithms, including the CE-marked algorithm LiverPRO, to support better-informed clinical decisions, from timely fibrosis risk identification to the surveillance of liver cancer.

Volixibat Improves Pruritus in Phase 2b PSC Trial

On May 4, 2026, Mirum Pharmaceuticals reported volixibat met the primary endpoint in the phase 2b VISTAS trial in adults with PSC and cholestatic pruritus, a symptom with limited treatment options and no approved PSC-specific therapies in the US. In the trial, the investigational ileal bile acid transporter (IBAT) inhibitor produced a statistically significant placebo-adjusted reduction in itch severity over 28 weeks.