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Y-mAbs Reports EMA's Acceptance of Pediatric Investigation Plan for Omburtamab

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Y-mAbs Reports EMA's Acceptance of Pediatric Investigation Plan for Omburtamab

Shots:

  • EMA has agreed to the Y-mAbs’ proposed Pediatric Investigation Plan (“PIP”) for Omburtamab which follows EMA’s Pediatric Committee’s positive opinion
  • The PIP approval allows Y-mAbs to file MAA of Omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma with its anticipated submission in H2’20
  • Omburtamab is mAb targeting B7-H3- being developed by Y-mAbs to treat CNS/leptomeningeal metastases from neuroblastoma- indication targeted by the PIP + number of additional cancer indications

Click here to­ read full press release/ article | Ref: Y-mAbs | Image:  Y-mAbs


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