On September 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a meeting of the Oncologic Drugs Advisory Committee ("ODAC") of the U.S. Food and Drug Administration ("FDA") has been scheduled for October 28, 2022 to review the Company’s Biological License Application ("BLA") for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct (Press release, Y-mAbs Therapeutics, SEP 1, 2022, View Source [SID1234618951]). Y-mAbs resubmitted the BLA for OMBLASTYS on March 31, 2022, and the FDA assigned a Prescription Drug User Fee Act ("PDUFA") goal date of November 30, 2022, for the completion of its priority review of the OMBLASTYS BLA.

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"We look forward to the October 28, 2022 meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about OMBLASTYS and the important data, which we believe supports approval," said Thomas Gad, President, and Interim Chief Executive Officer. "This is another key step towards providing a potential treatment for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma."

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