Omeros (OMER) said Thursday that results from a statistical analysis of narsoplimab, its monoclonal antibody to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, showed robustness of the previously reported primary endpoint analysis.
The company said that newly completed sensitivity analyses confirm the survival benefit of narsoplimab in patients with hematopoietic stem cell TA-TMA. The results support the previously reported findings that narsoplimab-treated patients had a significant reduction in the risk of mortality.
Omeros added that it plans to resubmit the biologics license application for narsoplimab to the US Food and Drug Administration later this quarter, aiming for it to become the first approved treatment for TA-TMA, with a European submission planned for mid-year.
Omeros shares were higher 2% in recent trading.
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