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PDS Biotechnology Updates Phase 3 Trial Design for PDS0101

Story Highlights
  • PDS Biotechnology is advancing PDS0101 for HPV16-positive head and neck cancers using immunotherapy combinations.
  • In January 2026, PDS Biotech moved to make progression-free survival the primary endpoint in its Phase 3 VERSATILE-003 trial to support a potentially faster regulatory path for PDS0101, backed by encouraging prior trial results.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
PDS Biotechnology Updates Phase 3 Trial Design for PDS0101

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PDS Biotechnology ( (PDSB) ) just unveiled an update.

On January 9, 2026, PDS Biotechnology announced it had submitted a protocol amendment to the U.S. Food and Drug Administration for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer, following a constructive Type C meeting with the agency in December 2025. The amendment designates progression-free survival as the primary endpoint that can be evaluated earlier, potentially shortening trial duration and supporting an accelerated approval pathway, while median overall survival and safety remain key requirements for full approval, a move underpinned by positive final results from the earlier VERSATILE-002 study showing promising survival and durable progression-free outcomes.

The most recent analyst rating on (PDSB) stock is a Hold with a $0.80 price target. To see the full list of analyst forecasts on PDS Biotechnology stock, see the PDSB Stock Forecast page.

Spark’s Take on PDSB Stock

According to Spark, TipRanks’ AI Analyst, PDSB is a Neutral.

The score is held down primarily by very weak financial performance (no revenue, ongoing large losses/cash burn, and a shrinking equity base alongside meaningful debt). Technicals also signal a pressured downtrend (price below key moving averages, negative MACD). Offsetting these, the latest call and recent corporate updates show meaningful clinical/regulatory progress and strengthened IP, but cash runway and trial timing remain notable risks.

To see Spark’s full report on PDSB stock, click here.

More about PDS Biotechnology

PDS Biotechnology is a late-stage immunotherapy company focused on developing treatments that harness the immune system to target and kill cancers, with a pivotal program in advanced HPV16-positive head and neck squamous cell cancers. Its lead investigational product, PDS0101 (Versamune® HPV), is being developed in combination with standard-of-care immune checkpoint inhibitors and in a triple regimen that includes PDS01ADC, an IL-12 fused antibody-drug conjugate, plus a checkpoint inhibitor.

Average Trading Volume: 781,779

Technical Sentiment Signal: Sell

Current Market Cap: $52.15M

For detailed information about PDSB stock, go to TipRanks’ Stock Analysis page.

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