FDA Accepts Omeros' BLA Resubmission For Narsoplimab

(RTTNews) - Omeros Corporation (OMER) Tuesday said that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

Prescription Drug User Fee Act (PDUFA) target action date or a decision from the regulator is expected in late September this year.

Omeros is also planning to submit a marketing authorization application (MAA) to the European Medicines Agency for narsoplimab in TA-TMA later this quarter.