PDS Biotechnology shares surge 14.24% premarket after FDA accepts Type C Meeting to discuss accelerated approval pathway for PDS0101 in HPV16-positive cancer.

PDS Biotechnology surged 14.24% in premarket trading following the announcement of an FDA-accepted Type C Meeting to discuss an accelerated approval pathway for PDS0101 in HPV16-positive head and neck cancer. The meeting aims to amend the VERSATILE-003 Phase 3 trial to use progression-free survival (PFS) as a surrogate primary endpoint, enabling faster regulatory evaluation based on positive VERSATILE-002 trial results. This development signals potential expedited approval, which could accelerate patient access to the therapy while retaining overall survival as the primary endpoint for full approval. The news aligns with investor optimism over regulatory progress and the drug’s clinical potential.