---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-064544"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2024-05-23T23:59:59+00:00"
generated_at: "2026-06-01T09:30:39.205079+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Theriva Biologics receives FDA Fast Track Designation for VCN-01 in metastatic pancreatic cancer

## Summary
- FDA granted Fast Track Designation for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic adenocarcinoma.
- VCN-01 is being evaluated in the ongoing Phase 2b VIRAGE trial as first-line therapy for pancreatic ductal adenocarcinoma.
- Enrollment in VIRAGE expected to complete in Q3 2024.
- Previously, FDA granted orphan drug designation to VCN-01 for PDAC.

## SEC filing metadata
- accession: 0001104659-24-064544
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2024-05-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/0001104659-24-064544-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/tm2415354d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-064544
- JSON: https://secwatch.observer/filing/0001104659-24-064544.json
- Plain text: https://secwatch.observer/filing/0001104659-24-064544.txt

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