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pdufa.bio

Bepirovirsen

Updated ยทnext FDA decision on the calendar

Bepirovirsen is a GSK plc program in Chronic hepatitis B. Its PDUFA date is Oct 26, 2026, the FDA's goal date to complete review of the application. Every date links its source.

GSK catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Chronic hepatitis B. Sponsor: GSK plc (GSK). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 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.

Catalyst history

PDUFA · Oct 26, 2026GSK

Questions

When is Bepirovirsen's next FDA decision or readout?

Bepirovirsen's PDUFA date is Oct 26, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Bepirovirsen's most recent FDA decision?

No FDA decision for Bepirovirsen is in our archive yet.

What is Bepirovirsen used for?

In our records Bepirovirsen is under review or in development for Chronic hepatitis B.

Who makes Bepirovirsen?

GSK plc (GSK).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.