By Chris Wack

 

Y-mAbs Therapeutics Inc. shares were up 10% to $13 after the company said it completed the resubmission of its Biologics License Application for I-omburtamab to the U.S. Food and Drug Administration.

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 biopharmaceutical company said 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 publish later this year.

Researchers at Memorial Sloan Kettering Cancer Center developed omburtamab, which is exclusively licensed to Y-mAbs. As a result of this licensing arrangement, Memorial Sloan Kettering has institutional financial interests related to the compound.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

April 01, 2022 12:27 ET (16:27 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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