Omeros Corporation Reports Updated Results from Narsoplimab HSCT-TMA Clinical Trial and Highlights from Recent Clinical and CMC Meetings with FDA
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
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Source: Business Wire
– Results Surpass FDA-Agreed Efficacy Threshold – SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros’ human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).In recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros’ rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion.The efficacy threshol
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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