---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-065408"
form_type: "8-K"
ticker: "VIR"
cik: "0001706431"
company_name: "Vir Biotechnology, Inc."
filed_at: "2026-10-08T12:38:38+00:00"
generated_at: "2026-10-12T15:36:14.710801+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Vir Biotechnology's VIR-5500 wins FDA Fast Track in late-line mCRPC; Phase 3 set for 2027

## Summary
- FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for late-line metastatic castration-resistant prostate cancer (mCRPC).
- VIR-5500 is co-developed with Astellas Pharma Inc. under a global strategic collaboration; pivotal Phase 3 development is anticipated to begin in 2027.
- Phase 1 study spans six dose-expansion cohorts: monotherapy in taxane-naive, radioligand therapy-naive and radioligand-exposed mCRPC.
- Combination cohorts test VIR-5500 with enzalutamide or docetaxel in early-line mCRPC, and with darolutamide in metastatic hormone-sensitive prostate cancer (mHSPC).
- Earlier 2026 Phase 1 data showed VIR-5500 was generally well tolerated with promising anti-tumor activity in mCRPC patients, per CEO Marianne De Backer.

## SEC filing metadata
- accession: 0001628280-26-065408
- form_type: 8-K
- ticker: VIR
- cik: 0001706431
- company_name: Vir Biotechnology, Inc.
- filed_at: 2026-10-08T12:38:38+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1706431/000162828026065408/0001628280-26-065408-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1706431/000162828026065408/vir-20261008.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-065408
- JSON: https://secwatch.observer/filing/0001628280-26-065408.json
- Plain text: https://secwatch.observer/filing/0001628280-26-065408.txt

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