---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-023093"
form_type: "8-K"
ticker: "IONS"
cik: "0000874015"
company_name: "IONIS PHARMACEUTICALS INC"
filed_at: "2026-05-28T16:41:22+00:00"
generated_at: "2026-05-28T16:42:18.793427+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Bepirovirsen Phase 3 achieves 19% functional cure rate in chronic hepatitis B; Q3 2026 FDA decision expected

## Summary
- 19% functional cure rate (233/1,220) vs 0% placebo (p<0.001) in overall population (HBsAg ≤3000 IU/mL).
- 26% functional cure rate in patients with ≤1000 IU/mL HBsAg, representing ~45% of diagnosed CHB cases globally.
- 49% of bepirovirsen recipients achieved qHBsAg ≤100 IU/mL one year post-treatment in exploratory analysis.
- Bepirovirsen under priority FDA review (Breakthrough/Fast Track); first regulatory decisions anticipated in Q3 2026.
- Ionis eligible for tiered royalties of 10-12% on net sales plus milestones under 2019 GSK license.

## SEC filing metadata
- accession: 0001140361-26-023093
- form_type: 8-K
- ticker: IONS
- cik: 0000874015
- company_name: IONIS PHARMACEUTICALS INC
- filed_at: 2026-05-28T16:41:22+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/874015/000114036126023093/0001140361-26-023093-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/874015/000114036126023093/ef20075060_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-023093
- JSON: https://secwatch.observer/filing/0001140361-26-023093.json
- Plain text: https://secwatch.observer/filing/0001140361-26-023093.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.