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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 Submission of Naxitamab Biologics License Application to U.S. FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Gets U.S. FDA Acceptance of Biologics License Application for Danyelza\u2122 in Neuroblastoma for Priority Review","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Memorial Sloan Kettering Cancer Center","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs\u2019 Nivatrotamab for the Treatment of Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Update on Omburtamab in DIPG","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Y-mAbs\u2019 DANYELZA\u00ae (naxitamab-gqgk) for the Treatment of Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Y-mAbs Therapeutics, Takeda Ink Exclusive License and Distribution Agreement for DANYELZA and Omburtamab in Israel","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Swixx BioPharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Y-mAbs Signs Distribution Agreement with Swixx for DANYELZA\u00ae and Omburtamab in Eastern Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs\u2019 177Lu-Omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion by EMA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs to Host Key Opinion Leader Webinar on DANYELZA\u00ae (naxitamab-gqgk) Frontline and HITS Data in High-Risk Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs\u2019 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Granted Rare Pediatric Disease Designation by FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"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 Completion of 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 2022","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 Submission of Omburtamab Biologics License Application to FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","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 Presentation of SADA Technology at AACR","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"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"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Memorial Sloan Kettering Cancer Center","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs' Announces Clearance of IND for GD2-SADA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Isotope Technologies Munich","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Scheduling of FDA Advisory Committee Meeting for Omburtamab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Memorial Sloan Kettering Cancer Center","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Regulatory Filing for DANYELZA\u00ae (naxitamab-gqgk) in Brazil","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces Pivotal Data for Omburtamab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","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 Outcome of FDA Advisory Committee Meeting on Omburtamab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","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 Complete Response Letter for Omburtamab Biologics License Application","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","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\u2019 DANYELZA\u00ae (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"WEP Clinical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS\/LM Metastasis from Neuroblastoma in Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","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 and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs DANYELZA (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in Brazil","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]

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              Y-mAbs Therapeutics

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              Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA

              Details:

              CD38-SADA is the program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy Theranostic Platform (SADA Y-PRIT), and is being investigated for the treatment of Relapsed or Refractory non-Hodgkin Lymphoma.

              Lead Product(s): CD38-SADA,177Lu-DOTA

              Therapeutic Area: Oncology Product Name: CD38-SADA

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 17, 2023

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              Y-mAbs DANYELZA (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in Brazil

              Details:

              Danyelza® (naxitamab-gqgk) binds to the glycolipid GD2, indicated in combination with GMCSF, for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response to prior therapy.

              Lead Product(s): Naxitamab-gqgk,GM-CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 23, 2023

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              Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA

              Details:

              The GD2-SADA construct was created using the Company’s SADA platform. SADA utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target.

              Lead Product(s): GD2-SADA,177Lu-DOTA

              Therapeutic Area: Oncology Product Name: GD2-SADA

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 05, 2023

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              Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

              Details:

              Danyelza® (naxitamab-gqgk) binds to the glycolipid GD2, indicated in combination with GMCSF, for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response to prior therapy.

              Lead Product(s): Naxitamab-gqgk,GM-CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 02, 2023

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              Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe

              Details:

              Danyelza (naxitamab-gqgk) is a humanized, monoclonal antibody that binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves.

              Lead Product(s): Naxitamab-gqgk,GM-CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: WEP Clinical

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership December 21, 2022

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              The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

              Details:

              CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator.

              Lead Product(s): 131I-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 December 16, 2022

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              Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China

              Details:

              DANYELZA (naxitamab) is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered three times in a week in an outpatient setting and is repeated every four weeks.

              Lead Product(s): Naxitamab,GM-CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 08, 2022

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              Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application

              Details:

              Omblastys® (131I-omburtamab) is being developed for the treatment of CNS/LM metastases in pediatric patients with neuroblastoma. 131I-omburtamab is an iodine-131 radiolabeled murine monoclonal antibody that recognizes and binds selectively to the B7-H3 antigen.

              Lead Product(s): 131I-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 December 01, 2022

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              Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab

              Details:

              Omblastys (omburtamab), a radiolabeled monoclonal antibody 8H9, is being developed to target B7-H3–expressing cells in human solid tumors, including embryonal tumors, carcinomas, sarcomas, and brain tumors.

              Lead Product(s): 131I-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 October 28, 2022

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              Y-mAbs Announces Pivotal Data for Omburtamab

              Details:

              OMBLASTYS® (131I-omburtamab),targets tumors that express B7-H3 for the treatment of CNS/leptomeningeal metastasis from neuroblastoma, interim results for 32 patients enrolled showed twelve-month overall survival (“OS”) of 73.5%, with a median follow-up of 25 months.

              Lead Product(s): 131I-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 October 03, 2022

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