The Pharmaletter

Omeros

A USA-based biopharmaceutical company headquartered in Seattle, Washington. The company develops and commercializes therapies for rare and immune-mediated diseases, with clinical and commercial activities supported through external partners and international trial sites.

Founding and History

Founded in 1994, Omeros is publicly traded on Nasdaq under the ticker OMER. The company has built its strategy around complement-pathway biology and immune-mediated disease, progressing programs from discovery through late-stage development and, more recently, regulatory approval.

Therapy Areas and Focus

Omeros’ portfolio is focused on complement-driven and immune-mediated conditions, with current emphasis on:

Transplant-associated thrombotic microangiopathy following hematopoietic stem cell transplant
Rare hematologic diseases linked to complement activation, including paroxysmal nocturnal hemoglobinuria
Complement-mediated kidney diseases, including IgA nephropathy

Technology Platforms and Modalities

Omeros develops monoclonal antibody therapeutics that inhibit specific components of the complement system. Its primary mechanisms target mannan-binding lectin–associated serine proteases, including MASP-2 and MASP-3, to modulate complement activation in disease settings.

Key Personnel

Gregory A. Demopulos, MD, serves as Chairman and Chief Executive Officer.

Strategic Partnerships

In October 2025, Omeros entered a global licensing agreement with Novo Nordisk covering development and commercialization of the MASP-3 inhibitor zaltenibart. The company also relies on external partners for manufacturing and clinical execution across its portfolio.

FAQ Section

Omeros’ platform is based on targeted inhibition within the complement system, with a focus on lectin- and alternative-pathway biology through monoclonal antibodies against MASP-2 and MASP-3.

The company focuses on rare and severe immune-mediated diseases where complement activation plays a central role, including transplant complications, rare hematologic disorders, and kidney diseases.

Omeros markets Yartemlea, a MASP-2 inhibitor approved in the U.S. for HSCT-associated thrombotic microangiopathy. Development programs include narsoplimab in IgA nephropathy and the MASP-3 inhibitor zaltenibart in late-stage development for paroxysmal nocturnal hemoglobinuria.

In December 2025, the U.S. FDA approved Yartemlea for treatment of HSCT-associated thrombotic microangiopathy in adults and children aged two years and older. In October 2025, Omeros announced a global licensing agreement with Novo Nordisk for zaltenibart.

Omeros has disclosed data supporting regulatory approval of Yartemlea based on survival outcomes in treated patients compared with external controls. Additional clinical data for pipeline programs are reported as studies progress.

Near-term priorities include U.S. commercial execution for Yartemlea and continued regulatory and development activities for pipeline programs, including partner-led advancement of zaltenibart.

Omeros is led by a long-standing management team with experience advancing complement-pathway therapeutics through late-stage development, regulatory review, and global partnering.

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