Y-mAbs Asked To Submit Additional Granularity Of Data For Omburtamab In Nerve Tissue Cancer

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  • Y-mAbs Therapeutics Inc YMAB recently concluded a Type B meeting with the FDA regarding omburtamab in CNS/leptomeningeal metastasis from neuroblastoma. 
  • The company received requests from the agency for additional data concerning the granularity of data from identified historical control groups.
  • Omburtamab is an investigational monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration.
  • B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
  • This additional granularity data will be submitted by the end of April.
  • Another Type B meeting has been scheduled for June 1 to discuss the review of the additional data.
  • The company aims at resubmitting the marketing application for omburtamab late in the second quarter or in the third quarter of 2021.
  • Also, the company is targeting the submission of an application to the European Medicines Agency on April 30.
  • Price Action: YMAB shares are up 2.7% at $26.14 in the market trading session on the last check Tuesday.
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