Omeros's Narsoplimab US Application Review Pushed By 3 Months, Shares Drop

Omeros Corporation OMER has revealed that the FDA needs additional time to review narsoplimab marketing application for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The new target action date is October 17, compared to the earlier date of July 17.
Omeros recently submitted a response to an FDA information request. FDA has classified the response as a major amendment, which requires additional time to review.
Price Action: OMER shares are down 12% at $14.92 on the last check Thursday.
Related content: Benzinga's Full FDA Calendar

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