The FDA decision on Y-mAbs Therapeutics Inc.’s (YMAB) Danyelza is slated for November 30, 2020.Danyelza, which is under priority review by the regulatory agency, is proposed for the treatment of patients with relapsed/refractory high-risk neuroblastoma, a rare pediatric cancer of the nervous system. Danyelza, known generically as Naxitamab, is a monoclonal antibody that targets GD2, an antigen overexpressed in certain tumors including neuroblastoma and melanoma.Y-mAbs submitted the Biologics License Application for Danyelza based on the safety and efficacy results of two pivotal phase II studies, dubbed 201 and 12-230.In the phase II trial known as Study 12-230 that involved 28 patients with primary refractory high-risk neuroblastoma, Danyelza demonstrated an overall objective response rate of 78% and the 2-year progression-free survival rate was 50%.According to the American Cancer Society, about 800 new cases of neuroblastoma are diagnosed each year in the United States.YMAB closed Friday’s (Oct.23, 2020) trading at $41.38, up 3.45%.