Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review
“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
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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Source: Y-mAbs Therapeutics, Inc