Gilead Sciences announced it has entered into a definitive agreement to acquire Ouro Medicines, a clinical-stage biotech focused on T cell engager therapies for autoimmune diseases, in a deal valued at $1.675 billion upfront with up to $500 million in additional milestone payments.
The acquisition strengthens Gilead’s inflammation and immunology portfolio by adding OM336, also known as gamgertamig, a BCMAxCD3 bispecific T cell engager currently in Phase 1/2 clinical trials. The therapy is designed to deplete pathogenic B cells and plasma cells, potentially enabling a durable immune reset after a limited treatment course.
Early clinical data suggests OM336 may deliver strong efficacy and a differentiated safety profile in severe antibody-mediated diseases, including autoimmune hemolytic anemia and immune thrombocytopenia. The therapy has received both Fast Track and Orphan Drug Designations from the FDA and is expected to enter registrational studies in 2027.
As part of the broader transaction strategy, Gilead is also in advanced discussions to collaborate with Galapagos on the development of the acquired assets. Under the proposed structure, Galapagos would fund 50% of the upfront and milestone payments and take on significant operational responsibilities, including absorbing Ouro’s workforce and covering development costs through early stages.
Gilead would retain global commercialization rights, except in Greater China where Keymed Biosciences holds existing rights, and would pay Galapagos royalties ranging from 20% to 23% on net sales.
The deal reflects Gilead’s continued push into innovative immunology approaches, particularly T cell engagers, which redirect a patient’s immune system to target disease-causing cells. This modality is increasingly seen as a potential alternative to chronic immunosuppression, with the possibility of long-term remission after limited treatment.
The transaction remains subject to customary regulatory approvals and closing conditions.
KEY QUOTES:
“This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases. BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care.”
Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead Sciences
“From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases. Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation, leveraging a proven track record in late stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences.”
Jaideep Dudani, PhD, Co-Founder And Chief Executive Officer of Ouro Medicines
