Omeros’ Narsoplimab Resubmission Gets Late Sept. Decision Date

May 6, 2025, 1:25 PM UTC

Omeros Corporation said the US FDA accepted its resubmitted biologics license application for narsoplimab and set a target decision date of late September.

  • Narsoplimab indicated to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy
  • Company expects interactive review by US FDA
  • Company sees EMA submission later this quarter

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Cameron Baker in Boston at cbaker225@bloomberg.net

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