The FDA decision on Narsoplimab, its treatment for post–stem cell and bone marrow transplant complications, is officially due on December 26.
Omeros said it had resubmitted its FDA application for Narsoplimab in March 2025, with the PDUFA target date later extended to Dec. 26, 2025.
- Narsoplimab analysis in a peer-reviewed study showed a sharp reduction in mortality risk compared with patients who received supportive care alone.
Decision on the company’s marketing application for Narsoplimab with the EMA is expected in mid-2026.Omeros Corp. (OMER) shares garnered retail attention in premarket trading on Wednesday as the market looked ahead to a key U.S. Food and Drug Administration (FDA) decision on Narsoplimab, its treatment for post–stem cell and bone marrow transplant complications, due on December 26.
Trading was halted at 06:36 a.m. pending news, according to Nasdaq data.
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