FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of High-Risk Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
Omeros Corporation (OMER)
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Source: Business Wire
– Discussions Ongoing with FDA and European Regulators for Expedited Approval – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy drug designation for OMS721, which last year received the designation from FDA for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. “TMA is an increasingly common complication followi
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OMER
Earnings
- 11/9/23 - Beat
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Sec Filings
- 4/1/24 - Form 10-K
- 4/1/24 - Form 8-K
- 3/27/24 - Form SC
- OMER's page on the SEC website