---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-168554"
form_type: "8-K"
ticker: "VIR"
cik: "0001706431"
company_name: "Vir Biotechnology, Inc."
filed_at: "2024-06-26T23:59:59+00:00"
generated_at: "2026-06-01T01:38:31.116563+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Vir Biotech gets FDA IND clearance & Fast Track for hepatitis delta combo therapy

## Summary
- FDA cleared IND and granted Fast Track for tobevibart + elebsiran for chronic hepatitis delta.
- Phase 2 SOLSTICE 24-week data expected Q4 2024; preliminary data showed high virologic response.
- Company plans ECLIPSE trial to support potential registration, comparing combo to standard of care.
- CEO Marianne De Backer says IND clearance underscores potential to transform treatment landscape.
- Hepatitis delta affects at least 12 million people globally; considered most severe viral hepatitis.

## SEC filing metadata
- accession: 0001193125-24-168554
- form_type: 8-K
- ticker: VIR
- cik: 0001706431
- company_name: Vir Biotechnology, Inc.
- filed_at: 2024-06-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1706431/000119312524168554/0001193125-24-168554-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1706431/000119312524168554/d835539d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-168554
- JSON: https://secwatch.observer/filing/0001193125-24-168554.json
- Plain text: https://secwatch.observer/filing/0001193125-24-168554.txt

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