Y-mabs announces fda acceptance of biologics license application for omblastys® (omburtamab) for the treatment of neuroblastoma for priority review

New york, may 31, 2022 (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 the biologics license application (“bla”) for omblastys® (omburtamab) for the treatment of pediatric patients with cns/leptomeningeal metastasis from 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, 2022, under the prescription drug user fee act (“pdufa”). the agency also indicated in the bla filing communication letter that it is planning to hold an advisory committee meeting in october 2022 to discuss the application.
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