Hibsago (bepirovirsen) is a GSK plc program in chronic hepatitis B virus infection, in combination with nucleos(t)ide analogue therapy, in adults without cirrhosis on that therapy for at least 6 months with suppressed HBV DNA and HBsAg of 3,000 IU/mL or less (FDA-authorized test). The FDA approved it on Oct 20, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Hibsago is the brand name of bepirovirsen (the name it carries since FDA approval); this page tracks both names. FDA approval tracked on pdufa.bio: chronic hepatitis B virus infection, in combination with nucleos(t)ide analogue therapy, in adults without cirrhosis on that therapy for at least 6 months with suppressed HBV DNA and HBsAg of 3,000 IU/mL or less (FDA-authorized test) (approved Oct 20, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: GSK plc (GSK). Approval record: Priority Review with Breakthrough Therapy Designation; first FDA-approved antisense oligonucleotide for chronic hepatitis B. Per the FDA, two placebo-controlled trials (B-Well): Hibsago injected subcutaneously for up to 24 weeks alongside existing antiviral therapy; 24% of Hibsago patients met the criteria to stop their existing therapy versus none on placebo, and 19% still had the virus controlled with undetectable HBsAg 24 weeks after stopping all treatment. Boxed warning for serious liver reactions and low platelet counts; warnings for kidney function, vasculitis and injection errors. The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx companion diagnostic. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Hibsago (bepirovirsen); 1 FDA decision is on record below.
On Oct 20, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Hibsago (bepirovirsen) is FDA-approved for chronic hepatitis B virus infection, in combination with nucleos(t)ide analogue therapy, in adults without cirrhosis on that therapy for at least 6 months with suppressed HBV DNA and HBsAg of 3,000 IU/mL or less (FDA-authorized test) (approved Oct 20, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
GSK plc (GSK).
Yes. The FDA approved an application for Hibsago (bepirovirsen) on Oct 20, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.