FDA approves GSK's Hibsago for chronic hepatitis B in defined patient groups
The FDA approved Hibsago (bepirovirsen), licensed from Ionis to GSK, for chronic hepatitis B patients who meet set criteria. Ionis is eligible for milestones.
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what happened
The FDA approved Hibsago (bepirovirsen) for chronic hepatitis B patients who meet specified criteria. GSK holds the product under a license from Ionis Pharmaceuticals. In Phase 3 trials, 19% of patients achieved a functional cure, compared with 0% on placebo.
The information comes from TradingView, citing a press release from Ionis distributed by BusinessWire.
why it matters
For Ionis this is a milestone: a partnered asset is turning into a product that pays royalties. Under the terms, Ionis can receive milestone payments and tiered royalties of 10–12% on net sales, with no commercialization costs. The next question is how quickly the drug gains traction in the U.S.
market impact
Ionis (IONS): the approval opens royalty and milestone income, supporting the company's revenue outlook
tags
instruments
sources
- Ionis Pharmaceuticals, Inc. (IONS) FDA OK For Partnered HBV Drug Hibsago — TradingView, 21 October 2026 at 01:20 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
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