PDS Biotech requests FDA meeting to discuss expedited approval for PDS0101 in HPV16+ HNSCC

PDS Biotechnology Corp

Final VERSATILE-002 data: median PFS 6.3 months, median OS 39.3 months in recurrent/metastatic HPV16+ HNSCC.
Proposes amending Phase 3 VERSATILE-003 trial to add PFS as earlier primary endpoint for potential accelerated approval.
VERSATILE-003 temporarily paused during FDA review; currently enrolled patients continue treatment.
FDA meeting requested to expedite regulatory pathway based on strong survival results.

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