Y-mAbs resubmits U.S. marketing application for omburtamab to FDA

Apr. 01, 2022 9:47 AM ETY-mAbs Therapeutics, Inc. (YMAB)CMCBy: Dania Nadeem, SA News Editor

Cancer cells, 3D illustration

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  • Y-mAbs Therapeutics (NASDAQ:YMABannounced on Friday that it had completed the resubmission of its Biologics License Application for neuroblastoma therapy omburtamab to the U.S. Food and Drug Administration.
  • In Oct. 2020, the agency had issued Refusal to File letter regarding the company's marketing application for omburtamab in children with CNS/leptomeningeal metastasis from neuroblastoma.
  • The FDA had cited that certain parts of the Chemistry, Manufacturing and Control (CMC) module and the clinical module of the application required further detail.
  • The company said the submission was based on the safety and efficacy results from two Phase 2 studies, which it expects to publish later this year.

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