Wednesday, March 25, 2026

Gilead to acquire Ouro Medicines for clinical BCMAxCD3 program

Gilead Sciences has signed a definitive agreement to acquire Ouro Medicines, a privately held biotech focused on T cell engager therapies for autoimmune diseases. The transaction is intended to add a clinical-stage asset to Gilead’s growing inflammation and immunology portfolio.

OM336 moves into Gilead’s inflammation portfolio

The acquisition centers on OM336 (gamgertamig), a bispecific BCMAxCD3 T cell engager in clinical development. The candidate is designed to deliver rapid and deep B cell depletion after a limited, subcutaneously administered course of therapy. In ongoing Phase 1/2 studies, the companies report efficacy signals and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).

OM336 has received both Fast Track and Orphan Drug Designation from the U.S. FDA for AIHA and ITP. The program is expected to enter registrational studies in 2027.

Deal terms

Under the agreement, Gilead will acquire all outstanding equity of Ouro Medicines. The consideration includes $1.675 billion in upfront cash at closing, subject to customary adjustments, and up to $500 million in contingent milestone payments. Closing is subject to standard conditions, including regulatory clearance and the expiration or termination of certain regulatory filings.

Planned strategic collaboration with Galapagos

Gilead also said it is in advanced discussions with Galapagos on a potential R&D collaboration covering the acquired Ouro assets. As outlined, Galapagos would fund 50% of the upfront payment and 50% of any milestones and would take on substantially all operating assets of Ouro while retaining its employees.

For OM336, the companies would collaborate on development. Galapagos would be responsible for development costs through the initiation of registrational studies, with those registrational costs to be shared equally thereafter. Gilead would keep worldwide commercialization rights except for Greater China, where Keymed Biosciences already holds commercialization rights. The framework also includes royalties to Galapagos of 20% to 23% of net sales.

Rationale: BCMAxCD3 engagers and the “immune reset” concept

BCMA-targeted T cell engagers are being investigated as a targeted approach in severe inflammatory and autoimmune conditions by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s T cells toward BCMA-expressing plasma cells, the approach aims to reduce inflammation and improve organ-level disease and is being explored for the potential to achieve durable, drug-free remission in some settings. Gilead is positioning T cell engagers as complementary to its existing cell therapy capabilities.