[{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Naxitamab","moa":"","graph1":"Oncology","graph2":"Approved","graph3":"Y-mAbs Therapeutics","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"","sponsorNew":"Y-mAbs Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Y-mAbs Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Naxitamab","moa":"","graph1":"Oncology","graph2":"Approved","graph3":"Y-mAbs 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Find Clinical Drug Pipeline Developments & Deals for Naxitamab

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                          Top Deals by Deal Size (USD bn)

                          01

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          Details : The agreement aims for the development and commercialization in Japan of Danyelza (naxitamab) for high-risk neuroblastoma and, upon agreement by the parties, potentially relapsed osteosarcoma.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : $2.0 million

                          November 04, 2024

                          Lead Product(s) : Naxitamab

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Nobelpharma

                          Deal Size : $33.0 million

                          Deal Type : Licensing Agreement

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                          02

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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 repe...

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          December 08, 2022

                          Lead Product(s) : Naxitamab,GM-CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          September 26, 2022

                          Lead Product(s) : Naxitamab,GM-CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Memorial Sloan Kettering Cancer Center

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          May 26, 2022

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

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

                          Therapeutic Area : Oncology

                          Study Phase : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          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 neurobla...

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          September 10, 2021

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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...

                          Brand Name : DANYELZA

                          Molecule Type : Large molecule

                          Upfront Cash : Undisclosed

                          December 18, 2020

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Swixx BioPharma

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          07

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Undisclosed

                          December 04, 2020

                          Lead Product(s) : Naxitamab

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Y-mAbs Therapeutics

                          Deal Size : Undisclosed

                          Deal Type : Licensing Agreement

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                          08

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          November 25, 2020

                          Lead Product(s) : Naxitamab,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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 MS...

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          October 16, 2020

                          Lead Product(s) : Naxitamab

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          euroPLX 86 Munich
                          Not Confirmed
                          euroPLX 86 Munich
                          Not Confirmed

                          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.

                          Brand Name : Undisclosed

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          June 02, 2020

                          Lead Product(s) : Naxitamab

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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