FDA Approves GSK's Hibsago, an Ionis-Discovered Hepatitis B Drug With 19% Functional Cure Rate
IONS is trading near its 52-week low of $42.08 (7.4% above the low).
Summary
The FDA approved Hibsago (bepirovirsen) for chronic hepatitis B in adults without cirrhosis, a first-in-class RNA-targeted drug Ionis discovered and licensed to GSK in 2019. The Phase 3 B-Well trials showed a 19% functional cure rate versus 0% on placebo, and 26% in patients with HBsAg ≤1000 IU/ml — against a standard of care that typically achieves under 1%. Ionis doesn't book the sales, but it collects tiered royalties of 10-12% on net sales plus regulatory and sales milestones, so this is a durable, high-margin revenue stream rather than a one-time payment. The approval lands in a strong stretch for the pipeline: ZANVASTRO cleared the FDA in September, ulefnersen hit its Phase 3 endpoint, and Roche's sefaxersen posted positive interim data. GSK has additional regulatory decisions expected in multiple geographies in the coming months, each of which would trigger further milestone payments to Ionis.
At the time of this announcement, IONS was trading at $45.20 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $7.5B. The 52-week trading range was $42.08 to $86.74. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.