Omeros narsoplimab sensitivity analyses confirm survival benefit; BLA resubmission planned this quarter

OMEROS CORP

Sensitivity analyses show HR 0.24–0.42 vs external control, p-values 0.0124 to <0.00001, confirming primary endpoint robustness.
Primary endpoint (Dec 19): HR=0.32 (95% CI 0.23–0.44), p<0.00001, over 3-fold mortality reduction in TA-TMA patients.
Omeros targets BLA resubmission to FDA later this quarter and European MAA submission by mid-year.
Narsoplimab has been well tolerated across trials with no safety signal of concern.

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