Omeros plunges deep­er af­ter FDA re­jects rare dis­ease drug, ask­ing for more in­for­ma­tion

Omeros prac­ti­cal­ly warned in­vestors that a com­plete re­sponse let­ter was com­ing when it dis­closed that the FDA found de­fi­cien­cies in its BLA for nar­so­plimab. But the agency did not elab­o­rate on the specifics of those de­fi­cien­cies for the drug, which was be­ing po­si­tioned as a treat­ment for the rare but se­ri­ous blood clot­ting dis­ease known as hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy (HSCT-TMA).

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