regulatory
confidence high
sentiment positive
materiality 0.90
PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval
PDS Biotechnology Corp
- 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.