NEW YORK, June 23, 2021 (GLOBE NEWSWIRE) -- 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, today announced that it has recently concluded a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
At the Type B meeting with the FDA, available data from external historical control groups and plans for statistical analyses to compare such data with the data from Study 03-133 were discussed. Based on our discussions with the FDA, we believe we now have a clearer path towards the resubmission of the omburtamab BLA to the FDA. Y-mAbs agreed to provide the agency with additional detailed data and the statistical analysis plan (“SAP”) and anticipates being able to do so during the third quarter of 2021. Upon receiving the FDA’s feedback on these items, we expect to move forward and request a Type B pre-BLA meeting. Pending a positive Type B pre-BLA meeting, we aim to initiate rolling resubmission of the omburtamab BLA by the end of the year.
“Although we are moving the timeline into the fourth quarter, we believe we now have a clearer path towards the resubmission of the BLA for omburtamab, which, if approved, would address an important unmet medical need,” stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, “We are very pleased to be aligned with the FDA on the next step towards the resubmission of the omburtamab BLA, and believe that, if approved, omburtamab can be of significant benefit to children 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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
Forward-Looking Statements
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DANYELZA and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
