FDA on board with endpoint for pivot study of Omeros’ narsoplimab

Omeros (NASDAQ:OMER) is up 12% premarket on modest volume on the heels of its announcement that the FDA has agreed on the primary endpoint for its pivotal study evaluating lead candidate narsoplimab (OMS721) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a Breakthrough Therapy-tagged indication.

The response-based primary endpoint needs to demonstrate a beneficial effect on the underlying HSCT-TMA disease process and a meaningful clinical improvement. It will include laboratory measures, organ function biomarkers and platelet and red blood cell transfusion burden.

The company says it is confident of a successful outcome.

https://seekingalpha.com/news/3477102-fda-board-endpoint-pivot-study-omeros-narsoplimab-shares-12-percent-premarket