Omeros served with CRL for narsoplimab in the treatment of HSCT-TMA

19 October 2021

Shares of Omeros Corporation (Nasdaq: OMER) plummeted nearly 27% to $5.67 by close of trading Monday, as the US biotech revealed another setback in its development of narsoplimab.

The company said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Earlier this month, the FDA notified Omeros that its marketing application for narsoplimab could not be approved, as the US regulator has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at that time.

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