Ea­ger to tout piv­otal win, Omeros how­ev­er keeps key pa­ra­me­ters shroud­ed

Omeros has brought some stel­lar piv­otal da­ta to the FDA to build a case for its blood clot drug, nar­so­plimab. They just can’t say ex­act­ly how they got to the con­clu­sion yet.

Re­port­ing pre­lim­i­nary da­ta from its sin­gle-arm, open-la­bel tri­al, the Seat­tle-based biotech said 56% of the pa­tients — who were ex­pe­ri­enc­ing throm­bot­ic mi­croan­giopa­thy fol­low­ing hematopoi­et­ic stem cell trans­plants — re­ceiv­ing at least one dose of nar­so­plimab achieved com­plete re­spon­der sta­tus. Among the sub­set who re­ceived at least four weeks of dos­ing, 68% met the cri­te­ria.

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