Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review
NEW YORK, June 02, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) 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 the Biologics License Application (“BLA”) for Danyelza™ (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration (“FDA”). The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act (“PDUFA”). The Agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.
“We believe that the FDA’s acceptance of our BLA for priority review of our first leading antibody compound, Danyelza (naxitamab), is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that Danyelza, if approved, can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma,” stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer, continued, “We look forward to working with the Agency to bring Danyelza to appropriate patients. We are excited to move forward and plan for a seamless commercial launch of Danyelza (naxitamab), if approved.”
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.
Y-mAbs is a late-stage clinical 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 two pivotal-stage product candidates - Danyelza (naxitamab) and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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Y-mAbs Therapeutics, Inc.
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