Omeros corporation submits the first sections of the rolling submission of its biologics license application

Omeros corporation has submitted the first sections of the rolling submission of its biologics license application (bla) to the u.s. food and drug administration (fda) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma), a far-too-often deadly complication of stem-cell transplantation. narsoplimab, also known as “oms721,” is omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (masp-2). there currently is no approved product for the treatment or prevention of hsct-tma, and narsoplimab is the only drug in development for the treatment of hsct-tma with fda’s breakthrough therapy designation. narsoplimab also has been granted fda’s orphan drug designation for this indication.
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