Omeros stock craters as FDA cites deficiencies in application for HSCT-TMA drug
Omeros’ stock price fell by more than 40% in early trading Friday as the company disclosed that the FDA has found deficiencies in its application for narsoplimab as a treatment of the rare but serious blood clotting disease known as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
“FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time,” Omeros said in a statement. And although the FDA stated that the notification does not reflect a final decision on the information under review, these types of notifications from the FDA typically lead to CRLs.
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