---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-039656"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2025-10-29T23:59:59+00:00"
generated_at: "2026-05-17T01:37:36.927054+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech requests FDA meeting to discuss expedited approval for PDS0101 in HPV16+ HNSCC

## Summary
- Final VERSATILE-002 data: median PFS 6.3 months, median OS 39.3 months in recurrent/metastatic HPV16+ HNSCC.
- Proposes amending Phase 3 VERSATILE-003 trial to add PFS as earlier primary endpoint for potential accelerated approval.
- VERSATILE-003 temporarily paused during FDA review; currently enrolled patients continue treatment.
- FDA meeting requested to expedite regulatory pathway based on strong survival results.

## SEC filing metadata
- accession: 0001140361-25-039656
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2025-10-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036125039656/0001140361-25-039656-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036125039656/ef20057871_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-039656
- JSON: https://secwatch.observer/filing/0001140361-25-039656.json
- Plain text: https://secwatch.observer/filing/0001140361-25-039656.txt

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