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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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
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: ApprovedProduct 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
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2021
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Swixx BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 18, 2020
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Y-mAbs Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 04, 2020
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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.
Lead Product(s): Naxitamab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
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 IIProduct 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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