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Omeros issued a press release on May 20, 2021 “report[ing] that the U.S. Food and Drug Administration (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 (HSCT-TMA).” Investors were advised by Omeros that “[t]he new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021.”
On May 20, 2021, Omeros’s stock price fell $1.83 per share, or 10.78%, on this news, to close at $15.14.