---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-125774"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2024-12-05T23:59:59+00:00"
generated_at: "2026-05-29T07:54:10.486616+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Theriva Biologics receives FDA guidance for Phase 3 study of VCN-01 in metastatic pancreatic cancer

## Summary
- FDA advised stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel; VIRAGE Phase 2b should not be expanded into Phase 3.
- FDA generally agreed with Theriva's proposed Phase 3 design; no additional chemotherapy needed for PDAC.
- VIRAGE Phase 2b enrollment completed; final patient follow-up is underway.
- Additional FDA meeting planned after VIRAGE completion to discuss Phase 3 protocol details.

## SEC filing metadata
- accession: 0001104659-24-125774
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2024-12-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/894158/000110465924125774/0001104659-24-125774-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465924125774/tm2430229d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-125774
- JSON: https://secwatch.observer/filing/0001104659-24-125774.json
- Plain text: https://secwatch.observer/filing/0001104659-24-125774.txt

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