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A Phase III trial of OMS 721 for stem cell transplant-associated thrombotic microangiopathy

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A Phase III trial of OMS 721 for stem cell transplant-associated thrombotic microangiopathy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2024

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At a glance

  • Drugs Narsoplimab (Primary)
  • Indications Thrombotic microangiopathy
  • Focus Registrational; Therapeutic Use
  • Sponsors Omeros Corporation

    • Most Recent Events

    • 21 Nov 2024 According to an Omeros Corporation media release, If the analytical results support resubmission of the BLA, the company plans to finalize and resubmit the BLA as soon as possible. Following validation of results, Omeros will share publicly the outcome of the primary analysis and, as completed, additional analyses.
    • 21 Nov 2024 According to an Omeros Corporation media release, company received an update on its progress toward planned resubmission of its biologics license application (BLA) for narsoplimab, this is a awaiting feedback from U.S. Food and Drug Administration on revised statistical analysis plan (SAP) for the BLA. Company has now received FDA's response on revised SAP, has no other presubmission information requests pending and is not aware of any other impediment to resubmitting the narsoplimab BLA.
    • 09 Nov 2023 According to an Omeros Corporation media release, As part of our planned resubmission of our Biologics License Application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy, company submitted to FDA a formal statistical analysis plan to compare survival data from an already-identified external source. The company continue to target an FDA approval decision on our resubmitted BLA in mid-2024.

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