PDS Biotechnology Submits Protocol Amendment for VERSATILE-003 Trial to FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
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PDS Biotechnology announced that the Company has submitted a protocol amendment to the U.S. 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 remains the primary endpoint for full approval as originally recommended by FDA. 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.
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Analyst Views on PDSB
Wall Street analysts forecast PDSB stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PDSB is 9.00 USD with a low forecast of 3.00 USD and a high forecast of 15.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.872
Low
3.00
Averages
9.00
High
15.00
Current: 0.872
Low
3.00
Averages
9.00
High
15.00
About PDSB
PDS Biotechnology Corporation is a clinical-stage immunotherapy company. The Company is developing a pipeline of targeted cancer immunotherapies based on its Versamune T cell-activator and Versamune in combination with its interleukin 12 (IL-12) fused antibody drug conjugate (ADC), PDS01ADC, a tumor targeting immunocytokine. PDS0101 is its lead Versamune based immunotherapy. PDS0101 combines Versamune with a mixture of short proteins (peptides) derived from the cancer-causing HPV16 viral protein. Versamune is a proprietary lipid nanoparticle and T cell activating platform. PDS0301 is an investigational tumor-targeting antibody conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency, infiltration, and longevity of T cells in the tumor microenvironment. Its Versamune immunotherapies and Versamune in combination with PDS01ADC, are utilized for treatments in oncology, and Infectimune is utilized for preventive vaccines against infectious agents.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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