Omeros (OMER) said Thursday that its pivotal trial of narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy met its primary endpoint in overall survival.
The company said an independent analysis compared overall survival of the trial's 28 patients with
over 100 similarly high-risk patients who did not receive narsoplimab treatment, and results showed "statistically significant superiority" of overall survival data from the trial's patients.
Omeros said it plans to resubmit the biologics license application for narsoplimab to the US Food and Drug Administration as soon as possible.
Shares of Omeros were up over 48% in early trading.
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