Designation is based on data from the clinical development program which demonstrated clinical proof of conceptFelzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 developmentFDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and which have potential to show substantial improve ...