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Y-mAbs Reports the Submission of Naxitamab's BLA to the US FDA for Relapsed/Refractory High-Risk Neuroblastoma

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Y-mAbs Reports the Submission of Naxitamab's BLA to the US FDA for Relapsed/Refractory High-Risk Neuroblastoma

Shots:

  • Y-mAbs has submitted the BLA the US FDA under the FDA’s Rolling Review process for naxitamab following the market closure on Mar 31- 2020
  • The BLA submission is based on two P-II studies- 201 and 12-230 assessing the safety & efficacy of the therapy- which the company expects to present at a venue later this year
  • Naxitamab is an investigational mAb- targeting GD2 having the potential to address the unmet medical needs of patients with relapsed/refractory high-risk neuroblastoma. The therapy was initially developed by MSK and exclusively licensed to Y-mAbs

Click here to­ read full press release/ article | Ref: Y-mAbs | Image: Y-mAbs


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