Ouro Medicines Receives U.S. FDA Fast Track Designation for Gamgertamig in Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

Gamgertamig previously received Orphan Drug Designation (ODD) for development in immune thrombocytopenia and autoimmune hemolytic anemia

SOUTH SAN FRANCISCO, Calif., Jan. 20, 2026 /PRNewswire/ -- Ouro Medicines, a clinical stage biotechnology company developing immune reset therapeutics for people living with chronic, immune-mediated diseases, today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody investigational candidate, has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for development in the treatment of autoimmune hemolytic anemia (AIHA) and for immune thrombocytopenia (ITP).

"Fast Track designation for gamgertamig in both AIHA and ITP underscores the need for new treatment options in these potentially life-threatening conditions," said Neely Mozaffarian, M.D., Ph.D., Chief Medical Officer of Ouro Medicines. "Our ongoing clinical trial of gamgertamig in autoimmune cytopenias, including AIHA and ITP, combined with our study in Sjögren's disease and idiopathic inflammatory myopathies, will continue to generate meaningful data in these indications, offering the potential of an immune reset approach which could redefine the standard of care for these immune-mediated conditions. We are highly encouraged by the data generated to date in Ouro-sponsored and investigator-initiated studies of gamgertamig in several indications."

Fast Track designation is intended to facilitate the development, and expedite the review, of new drugs that demonstrate the potential to treat serious conditions and fill an unmet medical need. Receiving Fast Track designation for a drug candidate enables more frequent interactions with the FDA and possible eligibility for accelerated approval and priority review. In addition, gamgertamig has been granted U.S. FDA Orphan Drug Designation (ODD) for development in the treatment of AIHA and ITP.

Ouro Medicines is evaluating gamgertamig in an open-label, multinational, basket study (NCT07083960) being conducted in the U.S. and Australia in adult participants with active autoimmune cytopenias, including relapsed/refractory AIHA, ITP, or both. The study evaluates safety, tolerability and pharmacokinetics of gamgertamig administered via subcutaneous injection, with the primary endpoint evaluated at Week 12. Dosing has been completed in the first cohort, with enrollment actively ongoing in subsequent cohorts.

In addition to development in autoimmune cytopenias, Ouro Medicines is conducting an open-label, multinational, basket study (NCT07229144) in adult participants with active, autoantibody-positive, relapsed/refractory Sjögren's disease or idiopathic inflammatory myopathy (which includes dermatomyositis, polymyositis, immune-mediated necrotizing myopathy and anti-synthetase syndrome). 

About Gamgertamig (OM336)

Gamgertamig (OM336) is an investigational BCMAxCD3 bispecific antibody designed to induce T cell-dependent cellular cytotoxicity of cells expressing BCMA, which are thought to drive certain immune-mediated diseases through the production of autoantibodies. By depleting these cell populations, it may be possible to offer patients extended periods of relief and avoid the challenges of treatment with immunosuppressive therapies.

With a CD3-targeting arm engineered for the reduced induction of T cell cytokines, referred to as a 'detuned' CD3-targeting arm, gamgertamig is designed to avoid severe immune activation while retaining potency of target cell depletion. This detuned arm may contribute to an expanded therapeutic index. Gamgertamig has a long half-life, which enables subcutaneous dosing, and has additional properties that may contribute to safety and tolerability.

Gamgertamig has a record of clinical evaluation across investigator-initiated and company-sponsored studies in oncology and in immune-mediated diseases, which has contributed to an understanding of its properties and potential applications. Gamgertamig has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) and Fast Track designation for development in the treatment of both autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).

About Autoimmune Cytopenias

Autoimmune cytopenias are diseases resulting primarily from autoantibody-mediated destruction of blood cells. These include autoimmune hemolytic anemia (AIHA), which affects red blood cells, and immune thrombocytopenia (ITP), which affects platelets. Both indications are potentially life-threatening. In AIHA, autoantibodies lead to the premature destruction of the body's red blood cells (known as hemolysis). Individuals with AIHA may experience signs and symptoms including debilitating fatigue, thromboembolism, dizziness, palpitations and shortness of breath. ITP occurs when the body's immune system attacks platelets, the blood cells that help control bleeding. This can lead to low platelet counts and hemorrhagic (bleeding) episodes that can be life-threatening.

About Ouro Medicines

Ouro Medicines is a clinical stage biotechnology company dedicated to developing immune reset therapeutics for people living with chronic immune-mediated diseases. Ouro's approach is focused on leveraging T cell engagers in B cell-mediated diseases to achieve immune resets that create durable remissions without ongoing immunosuppression. Based in San Francisco and launched in 2025, Ouro was founded by Monograph Capital in partnership with GSK. Ouro is also backed by leading investors TPG, NEA and Norwest. For more information visit www.ouromedicines.com or follow us on LinkedIn.

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SOURCE Ouro Medicines