---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-000786"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2026-01-09T23:59:59+00:00"
generated_at: "2026-05-16T11:03:09.646758+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval

## Summary
- On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.
- The amendment changes progression free survival (PFS) to a primary endpoint for earlier evaluation, potentially enabling accelerated approval of PDS0101.
- Median overall survival remains the primary endpoint for full approval as originally recommended by FDA.
- The amendment follows a constructive Type C meeting with the FDA in December 2025.
- The amendment is supported by positive final results from VERSATILE-002 trial showing promising mOS and durable PFS.

## SEC filing metadata
- accession: 0001140361-26-000786
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2026-01-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/0001140361-26-000786-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/ef20062601_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-000786
- JSON: https://secwatch.observer/filing/0001140361-26-000786.json
- Plain text: https://secwatch.observer/filing/0001140361-26-000786.txt

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