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A Phase III single arm pivotal study assessing narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)

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A Phase III single arm pivotal study assessing narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2024

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At a glance

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

    • Most Recent Events

    • 07 Aug 2024 According to an Omeros Corporation media release, the company has submitted an analysis plan to assess existing clinical trial data along with other evidence proposed to be included in a resubmission of our biologics license application (BLA) for narsoplimab in TA-TMA. The company is engaged in ongoing discussions with the FDA regarding the analysis plan and the other evidence proposed to be included in the submission. Meeting with FDA has been scheduled.
    • 20 Apr 2022 According to an Omeros Corporation media release, manuscript detailing the results of this trial was published online by JCO, the flagship publication of the American Society of Clinical Oncology.
    • 20 Apr 2022 According to an Omeros Corporation media release, data from this trial will be published in an upcoming volume of the Journal of Clinical Oncology (JCO).

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