---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-108958"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2024-10-16T23:59:59+00:00"
generated_at: "2026-05-30T14:14:32.285423+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# European Commission grants orphan designation to VCN-01 for retinoblastoma

## Summary
- Orphan medicinal product designation granted by European Commission for VCN-01 oncolytic adenovirus to treat retinoblastoma.
- FDA previously granted orphan drug and rare pediatric disease designations for same indication.
- Designation provides 10-year EU market exclusivity post-approval, protocol assistance, and fee reductions.
- Phase 1 trial in pediatric refractory retinoblastoma showed encouraging safety/activity with intravitreal VCN-01.
- Company working with physicians and regulators on VCN-01 as adjunct to chemotherapy.

## SEC filing metadata
- accession: 0001104659-24-108958
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2024-10-16T23:59:59+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/894158/000110465924108958/0001104659-24-108958-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465924108958/tm2426230d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-108958
- JSON: https://secwatch.observer/filing/0001104659-24-108958.json
- Plain text: https://secwatch.observer/filing/0001104659-24-108958.txt

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