PDS Biotechnology Gains FDA Meeting for PDS0101 Approval

PDS Biotechnology ( (PDSB) ) has issued an announcement.

On December 2, 2025, PDS Biotechnology announced that the FDA accepted its request for a Type C Meeting to discuss an accelerated approval pathway for its PDS0101 treatment in HPV16-positive head and neck cancer. This meeting, scheduled for December 2025, aims to explore amendments to the Phase 3 VERSATILE-003 trial, potentially expediting the treatment’s availability to patients based on positive results from the VERSATILE-002 trial.

The most recent analyst rating on (PDSB) stock is a Buy with a $3.00 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, with its investigational targeted immunotherapy PDS0101 being developed in combination with a standard-of-care immune checkpoint inhibitor and other combinations.

Average Trading Volume: 744,814

Technical Sentiment Signal: Strong Sell

Current Market Cap: $39.27M

See more data about PDSB stock on TipRanks’ Stock Analysis page.