Omeros Corporation Initiates BLA Submission for Narsoplimab for the Treatment of HSCT-TMA
Omeros Corporation (OMER)
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Source: Business Wire
– Rolling Submission of the Remaining BLA Sections Continues On Track for Scheduled Completion 1H 2020 – SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) has submitted the first sections of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a far-too-often deadly complication of stem-cell transplantation.Narsoplimab, also known as “OMS721,” is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). There currently is no approved product for the treatment or prevention of HSCT-TMA, and narsoplimab is the only drug in development for the treatment of HSCT-TMA with FDA’s breakthrough therapy designation. Narsoplimab also has been granted FDA’s orphan drug designation for this indication.Last month, Omeros announced that FDA had agreed with
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- Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
- Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial ResultsBusiness Wire
- Omeros Corporation to Announce Fourth Quarter and Year-End Financial Results on April 1, 2024Business Wire
OMER
Earnings
- 11/9/23 - Beat
OMER
Sec Filings
- 4/29/24 - Form DEF
- 4/29/24 - Form ARS
- 4/29/24 - Form 4
- OMER's page on the SEC website