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Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

Tuesday, October 20, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: GSK announced that the FDA has approved Hibsago (bepirovirsen) for treating chronic hepatitis B in adults without cirrhosis. This approval allows its use in combination with nucleos(t)ide analogue reverse transcriptase inhibitors for patients who have suppressed HBV DNA. The approval marks a significant advancement in hepatitis B treatment options.

Market Sentiment Analysis

POSITIVE FACTORS

  • Hibsago approved for chronic hepatitis B treatment.
  • FDA approval supports adult patients without cirrhosis.
  • Combination therapy with NrtI enhances treatment options.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+6%
120-day peak, hindsight
Typical move
1.6%
average across 15 past catalysts
Lead asset
Belimumab
Phase 2 · Systemic Sclerosis Associated Interstitial Lung Disease

Full Press Release Details

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg)

Frequently Asked Questions

What is Hibsago used for?

Hibsago is approved for treating chronic hepatitis B virus infection.

Who can receive Hibsago treatment?

It is for adult patients without cirrhosis on NrtI therapy.

What does NrtI therapy involve?

NrtI therapy includes nucleos(t)ide analogue reverse transcriptase inhibitors.

What is the significance of FDA approval?

FDA approval enhances treatment options for chronic hepatitis B.

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Tags: GSK Hibsago bepirovirsen chronic hepatitis B FDA approval
Last updated: Oct 20, 2026

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Lead asset
BelimumabPhase 2
Systemic Sclerosis Associated Interstitial Lung Disease →

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