regulatory
confidence high
sentiment positive
materiality 0.70
Corbus Pharma announces FDA alignment for CRB-701 accelerated path; CMO resigns
Corbus Pharmaceuticals Holdings, Inc.
- FDA agreed on registrational study designs for CRB-701 in second-line HNSCC and cervical cancer, with potential accelerated approval using ORR primary endpoint.
- Dr. Dominic Smethurst steps down as Chief Medical Officer, effective June 30, 2026.
- Updated CRB-701 monotherapy data accepted for presentation at ASCO 2026 (May 29-June 2).
- Company expects to report CRB-701 + Keytruda data in first-line HNSCC in Q4 2026; registrational study for HNSCC to start mid-2026.