Agenus Gains As Balstilimab US Application Accepted For Review In Cervical Cancer

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.