Lead Product(s) : Naxitamab
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Nobelpharma
Deal Size : $33.0 million
Deal Type : Licensing Agreement
Y-mAbs And Nobelpharma Sign DANYELZA® Deal for Japanese Market
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
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 repe...
Brand Name : Danyelza
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 08, 2022
Lead Product(s) : Naxitamab,GM-CSF
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Memorial Sloan Kettering Cancer Center
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
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
Lead Product(s) : Naxitamab,GM-CSF,Temozolomide
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
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
Study Phase : Approved
Sponsor : Swixx BioPharma
Deal Size : Undisclosed
Deal Type : Agreement
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...
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
Lead Product(s) : Naxitamab
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Y-mAbs Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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
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.
Brand Name : Danyelza
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 25, 2020
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 MS...
Brand Name : Danyelza
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 16, 2020
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
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