PDS Biotechnology Secures FDA Meeting to Discuss Accelerated Approval for PDS0101
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Source: Newsfilter
- FDA Meeting Approval: PDS Biotechnology's request for a Type C meeting with the FDA has been accepted, scheduled for this month to discuss the accelerated approval pathway for PDS0101 in HPV16-positive recurrent head and neck cancer, marking a significant advancement in the company's cancer immunotherapy efforts.
- Clinical Trial Results: The final results from the VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival, providing data support for the accelerated approval of PDS0101, potentially shortening the regulatory approval timeline.
- Trial Design Change: The company plans to amend the VERSATILE-003 Phase 3 trial to change the progression-free survival endpoint to a surrogate primary endpoint that can be evaluated earlier, enhancing statistical power and laying the groundwork for accelerated approval, thereby increasing market competitiveness.
- Strategic Outlook: PDS Biotechnology's CEO stated that the positive progression-free survival data offers a crucial opportunity to shorten the duration to a primary endpoint, which is expected to expedite treatment availability, meet patient needs, and enhance the company's position in the cancer treatment market.
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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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