Omeros Corporation announced on May 6, 2025, that the U.S. Food and Drug Administration (FDA) accepted for review the resubmission of its Biologics License Application (BLA) for narsoplimab. This BLA is for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
The resubmission was classified as a Class 2 resubmission, and the FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in late September 2025 for its decision. The BLA includes primary analyses demonstrating clinically meaningful and statistically significant improvements in survival associated with narsoplimab treatment.
The resubmission also incorporates data describing survival in Omeros’ expanded access program, where adult and pediatric TA-TMA patients were treated with narsoplimab. This acceptance and assigned PDUFA date provide a clear regulatory timeline for a potential approval of the company's lead asset.
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