---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-124523"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:12:44.028049+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# EMA provides positive Scientific Advice on Theriva's Phase 3 trial design for VCN-01 in metastatic PDAC

## Summary
- EMA CHMP agreed on Phase 3 design for VCN-01 + gem/nab-paclitaxel vs SoC; primary endpoint overall survival.
- CHMP agreed on repeated dosing in macrocycles, enabling >2 doses; recognized VIRAGE survival benefit.
- Theriva plans End-of-Phase 2 meeting with FDA in H1 2026 to finalize multinational Phase 3 trial.
- Cash runway into Q1 2027 ($15.5M at Nov 10, 2025) supports regulatory activities and partnering.
- VCN-01 has Orphan Drug designation in EU/US, Fast Track in US, and Rare Pediatric Disease for retinoblastoma.

## SEC filing metadata
- accession: 0001104659-25-124523
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2025-12-29T23:59:59+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/894158/000110465925124523/0001104659-25-124523-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465925124523/tm2534356d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-124523
- JSON: https://secwatch.observer/filing/0001104659-25-124523.json
- Plain text: https://secwatch.observer/filing/0001104659-25-124523.txt

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