Omeros' OMS721 receives orphan drug designation from FDA Omeros announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration for prevention of complement-mediated thrombotic microangiopathies. Omeros is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. Omeros expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in 1Q14.
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