On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for omburtamab (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551989]). The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee ("PDCO"). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

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As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

"We are pleased to announce this important regulatory milestone. The approval of the PIP provides Y-mAbs with a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. We look forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as soon as possible," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are preparing the European submission of the marketing authorization application for omburtamab, and plan for submission in the second half of 2020. This is a vital step forward in our efforts of bringing omburtamab to the market in Europe, and it demonstrates the close and constructive interactions established with the regulatory authorities in Europe.

Researchers at Memorial Sloan Kettering ("MSK") developed the therapeutic product referenced in this statement, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.