Y-mabs and the european medicines agency pediatric committee reach agreement on the pediatric investigation plan for omburtamab

Y-mabs therapeutics, inc. announced that the european medicines agency (“ema”) has agreed to the company’s proposed pediatric investigation plan (“pip”) for omburtamab. 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. 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. 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.
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