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Stock impact report

Omeros Corporation Streamlines Path to Biologics License Application for OMS721 in HSCT-TMA Following Meeting with FDA

Omeros Corporation (OMER) 
Last omeros corporation earnings: 3/2 04:03 pm Check Earnings Report
US:NASDAQ Investor Relations: investor.omeros.com
Company Research Source: Business Wire
Patient Data from Existing Single-Arm Study Will Form the Basis for BLA; No Historical Control Required SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today announced that, based on a recent meeting with the U.S. Food and Drug Administration (FDA), the company has streamlined the required work and further advanced its preparations for its Biologics License Application (BLA) for OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). OMS721 holds FDA’s breakthrough therapy designation as well as orphan drug designations from FDA and the European Medicines Agency (EMA) for HSCT-TMA. OMS721 is the company’s Phase 3 human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. Agreements reached during the recent FDA meeting are t Show less Read more
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