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

Dr_Microbe/iStock via Getty Images

  • 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.

Recommended For You

Comments

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.