Omeros Receives FDA Decision On Narsoplimab

Omeros Corp. (OMER) Tuesday said it received a decision from FDA on a formal dispute resolution request for Narsoplimab.

The decision proposes the resubmission of the narsoplimab biologics license application or BLA including a comparison of the existing response data from the completed pivotal trial. The specific approach to resubmission and its details would be determined through discussion with the review division, the company noted.

Omeros requested FDA's review division in June for the issuance of a complete response letter concerning the biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

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