Omeros stock craters as FDA cites de­fi­cien­cies in ap­pli­ca­tion for HSCT-TMA drug

Omeros’ stock price fell by more than 40% in ear­ly trad­ing Fri­day as the com­pa­ny dis­closed that the FDA has found de­fi­cien­cies in its ap­pli­ca­tion for nar­so­plimab as a treat­ment of the rare but se­ri­ous blood clot­ting dis­ease known as hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy (HSCT-TMA).

“FDA has iden­ti­fied de­fi­cien­cies that pre­clude dis­cus­sion of la­bel­ing and post-mar­ket­ing re­quire­ments/com­mit­ments at this time,” Omeros said in a state­ment. And al­though the FDA stat­ed that the no­ti­fi­ca­tion does not re­flect a fi­nal de­ci­sion on the in­for­ma­tion un­der re­view, these types of no­ti­fi­ca­tions from the FDA typ­i­cal­ly lead to CRLs.

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