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    [{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma CNS\/LM Metastasis","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS (omburtamab) for the Treatment of Neuroblastoma for Priority Review","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"}]

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              Y-mAbs Therapeutics

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              Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS (omburtamab) for the Treatment of Neuroblastoma for Priority Review

              Details:

              The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.

              Lead Product(s): Omburtamab

              Therapeutic Area: Oncology Product Name: Omblastys

              Highest Development Status: Phase II/ Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 31, 2022

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              Y-mAbs Therapeutics

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              Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma CNS/LM Metastasis

              Details:

              Y-mAbs Therapeutics requested a pre-BLA meeting for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.

              Lead Product(s): Omburtamab

              Therapeutic Area: Oncology Product Name: 131I-8H9

              Highest Development Status: Phase II/ Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 04, 2021

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              Y-mAbs Therapeutics

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              Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA

              Details:

              Omburtamab is an investigational, mAb that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.

              Lead Product(s): Omburtamab

              Therapeutic Area: Oncology Product Name: 131I-8H9

              Highest Development Status: Phase II/ Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 30, 2020

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              Y-mAbs Therapeutics

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              Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab

              Details:

              The Company reached alignment with the FDA on an Accelerated Approval Pathway for omburtamab along with a rolling BLA submission.

              Lead Product(s): Omburtamab

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase II/ Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 26, 2020

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