other material
confidence high
sentiment positive
materiality 0.65
PDS Biotech schedules FDA Type C meeting to discuss accelerated approval for PDS0101 in HNSCC
PDS Biotechnology Corp
- 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.