Y-mabs provides regulatory update on omburtamab for the treatment of patients with neuroblastoma cns/lm metastasis

New york, nov. 04, 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, based on feedback from the u.s. food and drug administration (“fda”) at a recent type b meeting, where the company provided the fda with additional detailed data and the statistical analysis plan, the company has requested a pre-bla meeting for omburtamab for the treatment of pediatric patients with cns/leptomeningeal metastasis from neuroblastoma. the company believes the pre-bla meeting will be held in january 2022, and pending a positive meeting, the company aims to initiate resubmission of the omburtamab bla shortly thereafter.
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