PDSB - PDS Biotech wins FDA Fast Track status for head and neck cancer therapy

Clinical-stage biotech, PDS Biotechnology (NASDAQ:PDSB) announced on Thursday that the U.S. Food and Drug Administration granted its Fast Track designation to its lead asset PDS0101 in combination with Merck’s (MRK) anti-PD-1 therapy, Keytruda for a certain type of head and neck cancer. PDS (PDSB) shares are trading ~4% higher in the pre-market Thursday in reaction. Specifically, the FDA has issued the designation for PDS0101 and Keytruda (pembrolizumab) in the treatment of recurrent or metastatic HPV16-positive head and neck cancer. Currently, PDS (PDSB) and Merck (MRK) are studying the therapeutic combination in a mid-stage trial called VERSATILE-002 for the condition. The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with an unmet medical need.  It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies. If certain criteria are met, such programs will also be able to win the

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PDS Biotech wins FDA Fast Track status for head and neck cancer therapy