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06 Aug 2020

Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA

Y-mAbs Therapeutics, Inc., a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that on August 5, 2020, the Company completed the submission of its Biologics License Application under the FDA’s Rolling Review process for omburtamab. Omburtamab is an investigational, monoclonal antibody 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 metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year.

Read the full press release here

  • Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA

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