Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors...
Brand Name : Omblastys
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 31, 2022
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Y-mAbs Therapeutics requested a pre-BLA meeting for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
Brand Name : 131I-8H9
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 04, 2021
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Omburtamab is an investigational, mAb that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from...
Brand Name : 131I-8H9
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 30, 2020
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab
Details : The Company reached alignment with the FDA on an Accelerated Approval Pathway for omburtamab along with a rolling BLA submission.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 26, 2020
Lead Product(s) : Omburtamab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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