Under Priority Review status, the FDA accepts for review Y-mAbs Therapeutics’ (NASDAQ:YMAB) marketing application for Danyelza (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma, a cancer that develops from immature nerve cells.
The agency’s action date is November 30.
Naxitamab is a humanized monoclonal antibody called 3F8 that targets a protein called GD2 that is expressed on tumors of neuroectodermal origin like neuroblastoma.
https://seekingalpha.com/news/3579532-fda-accepts-y-mabs-naxitamab-application-for-neuroblastoma
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