- The FDA has accepted for review Agenus Inc's AGEN marketing application seeking approval for balstilimab for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
- Under Priority Review status, the agency's target action date is December 16.
- Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2.
- Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus' zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: AGEN shares are up 10.1% at $5.50 during the market session on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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