Omeros (OMER) Announces Data on Narsoplimab in COVID-19 Patients
Zacks Investment Research | May 31, 2021 05:16AM ET
Omeros (NASDAQ:OMER) Corporation industry ’s rise of 4.3%.
We remind investors that narsoplimab enjoys Breakthrough Therapy and Orphan Drug designations in both hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and IgA nephropathy. The company recently announced that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of HSCT-TMA. The new target action date is Oct 17, 2021. The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request. The FDA has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review.
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