Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Bepirovirsen (IONIS-HBVRx) in Hepatitis B. The expected timing is based on the latest available company guidance and may change.
2/1/23 Initiated Ph3 trial. GSK presented positive data from the Ph2b B-Clear study. Presented data at the AASLD The Liver Meeting®. Ph3 data in 2026. 01/06/26:- Positive Ph3 B-Well 1/2 results; functional cure achieved. Global regulatory filings planned starting Q1 2026. 01/11/26:- Positive Ph3 B-Well CHB results highlighted; global regulatory submissions now broadly guided for 2026 with full data planned. 04/27/26:- NDA accepted for Priority Review; PDUFA October 26, 2026. EASL 2026 data May.' 05/27/26:- NEJM/EASL pooled B-Well 1/2 Ph3 showed 19% functional cure. First regulatory decisions expected Q3 2026.
Verification
Confirm timing and program details against the company announcement or filing.