PDSB - PDS Biotech jumps 13% as FDA clears further development of lead asset

• PDS Biotechnology ( NASDAQ: PDSB ), a biopharma focused on cancer immunotherapies, added 13% pre-market Monday after the company announced that a recent End-of-Phase 2 meeting with the FDA brought clarity to the late-stage development of its lead asset PDS0101.
• At the meeting, PDSB has submitted interim data to support the potential of PDS0101 against a particular form of head and neck squamous cell carcinoma (HNSCC) in combination with Merck's ( MRK ) anti-PD-1 therapy, Keytruda.
• "The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule," Chief Executive Frank Bedu-Addo remarked.
• The FDA has issued Fast Track designation to PDS0101/ Keytruda combo for recurrent or metastatic HPV16- positive head and neck cancer.

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