Omeros Corporation (NASDAQ:OMER) announced that the FDA will review its resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
According to the company, the resubmission was classified as a Class 2 and pursuant to the Prescription Drug User Fee Act has been assigned an FDA decision target date in late September 2025. The BLA resubmission includes the primary set of analyses comparing the overall survival of narsoplimab-treated patients to an external group of TA-TMA patients.
Additionally, Omeros is preparing a marketing authorization application for narsoplimab in TA-TMA, to be submitted to the EMA later this quarter.
