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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 Submission of Naxitamab Biologics License Application to U.S. FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 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 Gets U.S. FDA Acceptance of Biologics License Application for Danyelza\u2122 in Neuroblastoma for Priority Review","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":"Takeda Pharmaceutical","sponsor":"Y-mAbs Therapeutics","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\/ Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"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":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"},{"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\/ 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":"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":"Phase IV","country":"U.S.A","productType":"Large 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Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 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":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"},{"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":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"}]

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              Y-mAbs Therapeutics

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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: Phase IV 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 Therapeutics

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              Y-mAbs Announces Regulatory Filing for DANYELZA® (naxitamab-gqgk) in Brazil

              Details:

              DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor for treatment of pediatric patients 1 year of age and older and adult patients.

              Lead Product(s): Naxitamab,GM-CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Memorial Sloan Kettering Cancer Center

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 26, 2022

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              Y-mAbs Therapeutics

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              Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint

              Details:

              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): Naxitamab,GM-CSF,Temozolomide

              Therapeutic Area: Oncology Product Name: Danyelza

              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 26, 2022

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              Y-mAbs Therapeutics

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              Y-mAbs to Host Key Opinion Leader Webinar on DANYELZA® (naxitamab-gqgk) Frontline and HITS Data in High-Risk Neuroblastoma

              Details:

              DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma.

              Lead Product(s): Naxitamab,Granulocyte-macrophage Colony-stimulating Factor

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 10, 2021

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              Y-mAbs Therapeutics

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              Y-mAbs Signs Distribution Agreement with Swixx for DANYELZA® and Omburtamab in Eastern Europe

              Details:

              Swixx BioPharma will exclusively distribute DANYELZA to treat patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in Eastern Europe, including Russia.

              Lead Product(s): Naxitamab,Granulocyte-macrophage colony-stimulating factor

              Therapeutic Area: Oncology Product Name: DANYELZA

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Swixx BioPharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement December 18, 2020

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              Takeda Pharmaceutical

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              Y-mAbs Therapeutics, Takeda Ink Exclusive License and Distribution Agreement for DANYELZA and Omburtamab in Israel

              Details:

              Under the terms of the agreement, Takeda will employ its proven platform of sales, access, marketing and regulatory expertise to distribute DANYELZA and omburtamab, if approved, in the territory.

              Lead Product(s): Naxitamab

              Therapeutic Area: Oncology Product Name: Danyelza

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

              Partner/Sponsor/Collaborator: Y-mAbs Therapeutics

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement December 04, 2020

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              Y-mAbs Therapeutics

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              FDA Approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma

              Details:

              U.S. Food and Drug Administration has approved DANYELZA (naxitamab-gqgk) 40mg/10ml. DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.

              Lead Product(s): Naxitamab,GM CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 25, 2020

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              Y-mAbs Therapeutics

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              Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma

              Details:

              The central independent evaluation showed an overall rate of response (“ORR”) of 68% and the rate of complete response (“CR”) was 59% for the 22 patients. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs.

              Lead Product(s): Naxitamab

              Therapeutic Area: Oncology Product Name: Danyelza

              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 16, 2020

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              Y-mAbs Therapeutics

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              Y-mAbs Gets U.S. FDA Acceptance of Biologics License Application for Danyelza™ in Neuroblastoma for Priority Review

              Details:

              Biologics License Application for Danyelza™ (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration.

              Lead Product(s): Naxitamab

              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 June 02, 2020

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              Y-mAbs Therapeutics

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              Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA

              Details:

              The Company has completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for naxitamab after market close on March 31, 2020.

              Lead Product(s): Naxitamab

              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 April 01, 2020

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              Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
              One Pharma aims to be one of the leading generic companies in Europe.
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