Posted by Michael Wonder on 20 Jan 2026
Ouro Medicines receives US FDA fast track designation for gamgertamig in immune thrombocytopenia and auto-immune haemolytic anaemia
20 January 2026 - Ouro Medicines today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody investigational candidate, has been granted US FDA fast track designation for development in the treatment of auto-immune haemolytic anaemia and for immune thrombocytopenia.
Ouro Medicines is evaluating gamgertamig in an open-label, multinational, basket study being conducted in the U.S. and Australia in adult participants with active autoimmune cytopenias, including relapsed/refractory auto-immune haemolytic anaemia, immune thrombocytopenia, or both.
