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Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)

Wednesday, October 21, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: GSK, a partner of Ionis Pharmaceuticals, announced that the FDA has approved Hibsago (bepirovirsen) for treating chronic hepatitis B virus infection. This approval applies to adult patients without cirrhosis who have been on nucleos(t)ide analogue reverse transcriptase inhibitor therapy for at least six months. The treatment is intended for those with suppressed HBV DNA.

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POSITIVE FACTORS

  • Hibsago (bepirovirsen) received FDA approval.
  • Approved for chronic hepatitis B treatment.
  • Indicated for adult patients without cirrhosis.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+3%
120-day peak, hindsight
Typical move
3.8%
average across 15 past catalysts
Lead asset
AKCEA-ANGPTL3-LRx
Phase 2 · Familial Chylomicronemia Syndrome

Full Press Release Details

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced that the U.S. 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

Frequently Asked Questions

What is Hibsago approved 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 is the required NrtI therapy duration?

Patients must have been on NrtI therapy for at least six months.

What does FDA approval mean for Hibsago?

FDA approval allows Hibsago to be marketed for chronic hepatitis B treatment.

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Tags: IONS Hibsago bepirovirsen chronic hepatitis B GSK FDA approval
Last updated: Oct 21, 2026

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