Clinical Study DesignThe feedback from FDA supports a single Phase 3 for full approval based on events relating to disease progression, with no biopsy endpoint, making it easier to enroll and less costly to conduct.
Market PositionCCL24 is a novel target with potential to reduce both inflammation and fibrosis, which is a key point of differentiation for CM-101 among drugs in development for fibrotic/inflammatory conditions.
Regulatory ApprovalChemomab announced positive feedback from the FDA following its End-of-Phase 2 and Type C meetings to support advancing nebokitug into Phase 3 development for primary sclerosing cholangitis.