Gilead Sciences to Acquire Ouro Medicines to Strengthen T Cell Engager Programme for Autoimmune Diseases
Tuesday, March 24, 2026
Gilead Sciences has entered into a definitive agreement to acquire Ouro Medicines.
OM336 is an investigational BCMAxCD3 bispecific T cell engager designed for the treatment of autoantibody-driven immune-mediated diseases. It has received both Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration.
The acquisition brings OM336 (gamgertamig), a clinical-stage BCMAxCD3 T cell engager, into Gilead’s expanding inflammation portfolio. The therapy is designed to deliver rapid and deep B cell depletion through a limited subcutaneous treatment course. In ongoing Phase 1/2 studies, OM336 has shown strong efficacy along with a differentiated safety profile following a single treatment cycle in severe antibody-mediated orphan conditions, including autoimmune haemolytic anaemia (AIHA) and immune thrombocytopenia (ITP).
Gamgertamig has received both Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AIHA and ITP. The therapy is expected to progress into registrational studies in 2027.
The addition of OM336 aligns with Gilead’s strategy to advance innovative therapies for serious autoimmune diseases. BCMA is an established target, and emerging clinical data indicates its potential to deliver meaningful outcomes in autoimmune conditions. BCMA-targeted T cell engagers offer a differentiated approach aimed at achieving durable disease control, complementing Gilead’s broader inflammation pipeline and its existing cell therapy portfolio.
BCMA-targeted T cell engagers are being explored as a precision treatment approach for severe inflammatory and autoimmune diseases by targeting pathogenic B cells and plasma cells. By directing a patient’s T cells towards BCMA-expressing plasma cells, these therapies may help reduce inflammation, improve organ function, and potentially enable long-term remission without continuous immunosuppressive treatment.
Ouro Medicines has progressed the development of gamgertamig through multiple clinical trials. The acquisition is expected to support further development by leveraging Gilead’s capabilities in late-stage development and commercialisation. The programme was initially in-licensed from Keymed Biosciences, which retains development rights in Greater China.
Source: gilead.com