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PDS Biotechnology Seeks FDA Meeting for PDS0101 Approval

Story Highlights
  • PDS Biotechnology seeks expedited FDA approval for PDS0101 in HPV16-positive cancer.
  • Promising trial results could accelerate PDS0101’s availability, enhancing PDS Biotech’s market position.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
PDS Biotechnology Seeks FDA Meeting for PDS0101 Approval

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PDS Biotechnology ( (PDSB) ) has provided an update.

On October 29, 2025, PDS Biotechnology announced its request for a meeting with the FDA to explore an expedited approval pathway for its immunotherapy drug PDS0101, targeting HPV16-positive head and neck cancer. This decision follows promising results from the VERSATILE-002 trial, showing significant median progression-free and overall survival rates, and aims to amend the ongoing VERSATILE-003 trial to include progression-free survival as an earlier primary endpoint. This strategic move could potentially accelerate the drug’s availability to patients, positioning PDS Biotechnology as a leader in providing innovative cancer treatments.

The most recent analyst rating on (PDSB) stock is a Buy with a $5.00 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.

PDSB’s overall score reflects the typical high-risk, high-reward nature of early-stage biotech firms. The company’s strong clinical progress and cash position are significant positives, but financial sustainability and valuation concerns due to ongoing losses and reliance on external funding temper the outlook. Technical indicators suggest some positive momentum, albeit with caution.

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 transforming how the immune system targets and kills cancers. The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers, developing investigational targeted immunotherapy PDS0101 in combination with standard-of-care immune checkpoint inhibitors.

Average Trading Volume: 495,376

Technical Sentiment Signal: Sell

Current Market Cap: $43.87M

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

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