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Stock impact report

PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)

PDS Biotechnology Corporation (PDSB) 
Last pds biotechnology corporation earnings: 11/7 06:00 am Check Earnings Report
Company Research Source: GlobeNewswire
PRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month. The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival (mOS) and durable progression-free survival (PFS) in patients with CPS = 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accele Show less Read more
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