OMER - FDA extends review period for Omeros' narsoplimab BLA

Omeros (OMER) announces that the U.S. FDA will require additional time to review the Biologics License Application ((BLA)) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.The health regulator has set an action date of October 17, 2021.As part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request, which the health regulator has classified as a major amendment requiring additional time to review.Under Priority Review status, the FDA had accepted Omeros's Narsoplimab BLA, in January.

For further details see:

FDA extends review period for Omeros' narsoplimab BLA