regulatory
confidence high
sentiment positive
materiality 0.70
PDS Biotech amends Phase 3 VERSATILE-003 trial to add PFS endpoint for potential accelerated approval of PDS0101
PDS Biotechnology Corp
- 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.