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- 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 indicate 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.