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Omeros Slumps As FDA Extends Decision Date For Narsoplimab

fda march25 20may21 lt

Shares of Omeros Corp. (OMER) are down more than 16% Thursday, following news related to its lead drug candidate Narsoplimab.

What's driving the stock down?

Narsoplimab, proposed for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), was originally assigned a decision date of July 17, 2021 by the FDA.

Now, the decision date has been postponed to October 17, 2021, as the U.S. regulatory agency requires additional time to review the Narsoplimab Biologics License Application.

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a lethal complication of stem cell transplantation caused by endothelial cell damage, which is induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation.

Are there any approved drugs for HSCT-TMA?

Narsoplimab is the first drug to be submitted to the FDA for approval in HSCT-TMA, and it has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.

Market potential

If approved, Narsoplimab could achieve sales of $575 million globally in the indication of HCST-TMA by 2027, according to Global Data. (Source: Clinical Trials Arena).

OMER has traded in a range of $9.25 to $25.46 in the last 1 year. The stock is currently trading at $14.20, down 16.32%.

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