---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-043889"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2025-12-02T23:59:59+00:00"
generated_at: "2026-05-16T15:40:53.493196+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech schedules FDA Type C meeting to discuss accelerated approval for PDS0101 in HNSCC

## Summary
- FDA accepted Type C meeting request; meeting scheduled for December 2025.
- Agenda: proposed amendment to Phase 3 VERSATILE-003 for accelerated approval of PDS0101.
- Amendment would change PFS to surrogate primary endpoint; mOS remains for full approval.
- Based on positive VERSATILE-002 data showing mOS and durable PFS in CPS≥1 patients.
- Company expects FDA meeting minutes in January 2026.

## SEC filing metadata
- accession: 0001140361-25-043889
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2025-12-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/0001140361-25-043889-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/ef20060301_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-043889
- JSON: https://secwatch.observer/filing/0001140361-25-043889.json
- Plain text: https://secwatch.observer/filing/0001140361-25-043889.txt

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