---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-006229"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2026-02-20T23:59:59+00:00"
generated_at: "2026-05-16T01:26:23.460031+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech amends Phase 3 VERSATILE-003 trial to add PFS endpoint for potential accelerated approval of PDS0101

## Summary
- Adopted protocol amendment for Phase 3 VERSATILE-003 trial adding progression-free survival as interim primary endpoint.
- PFS endpoint supports potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer.
- Median overall survival remains primary endpoint for full approval, per prior FDA Type C meeting.
- FDA 30-day review period ended without objection; company proceeding with amended protocol.

## SEC filing metadata
- accession: 0001140361-26-006229
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2026-02-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036126006229/0001140361-26-006229-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036126006229/ef20066174_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-006229
- JSON: https://secwatch.observer/filing/0001140361-26-006229.json
- Plain text: https://secwatch.observer/filing/0001140361-26-006229.txt

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