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

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