Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS® (omburtamab) for the Treatment of Neuroblastoma for Priority Review
“We believe that the FDA’s acceptance of our OMBLASTYS® BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure. Further, OMBLASTYS® has a Rare Pediatric Disease Designation which, if approved, will provide Y-mAbs with a Priority Review Voucher, our second PRV, which would further strengthen our financial position as we would seek to monetize the OMBLASTYS® PRV,” stated
Researchers at
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.
Forward-Looking Statements
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DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of
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Source: Y-mAbs Therapeutics, Inc