Business
PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101 PRINCETON, N.J., Jan. 09, 2026 (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 the Company has submitted a protocol amendment to the U.S. Food & Drug Administrat
About this update from Pds Biotechnology Corporation
[{"type":"image","alt":"PDS Biotechnology Corporation","displaySize":"","headline":null,"caption":"PDS Biotechnology Corporation","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":42,"url":"https://media.zenfs.com/en/globenewswire.com/63fe962c3957c7a225a7c312a7c6913d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/6tw_s0aaD8Jse33jriazAg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTU5O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/63fe962c3957c7a225a7c312a7c6913d","width":300,"height":42}},"lazy":false},{"type":"text","content":"PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial","length":68,"tagName":"p"},{"type":"text","content":"Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101","length":89,"tagName":"p"},{"type":"text","content":"PRINCETON, N.J., Jan. 09, 2026 (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 the Company has submitted a protocol amendment to the U.S. Food & Drug Administration (“FDA”) for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.","length":753,"tagName":"p"},{"type":"text","content":"The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company’s VERSATILE-002 trial, which showed promising mOS and durable PFS.","length":357,"tagName":"p"},{"type":"text","content":"“Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of...