Upcoming FDA decision · October 26, 2026
Bepirovirsen PDUFA date: FDA decision expected October 26, 2026
10 days to goGSK plc (GSK) →
The FDA is expected to decide on Bepirovirsen from GSK plc in Chronic hepatitis B in adults by the PDUFA target action date of October 26, 2026. For Chronic hepatitis B in adults. NDA, Priority Review, Breakthrough Therapy; partnered with Ionis. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: us.gsk.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
October 26
Target action date
Phase 2
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Bepirovirsen?
- The FDA's PDUFA target action date for Bepirovirsen is October 26, 2026. The FDA can act before that date, and the review can be extended.
- What is Bepirovirsen being reviewed for?
- The application under FDA review covers Chronic hepatitis B in adults.
- Which company is developing Bepirovirsen?
- GSK plc (GSK).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).