Y-mAbs push­es back re-sub­mis­sion of its neu­rob­las­toma BLA to end of 2021

Y-mAbs Ther­a­peu­tics on Wednes­day again ad­just­ed its time­line for re-sub­mit­ting its neu­rob­las­toma drug om­bur­tam­ab to the FDA, say­ing the sub­mis­sion won’t like­ly hap­pen un­til the end of 2021.

“Y-mAbs agreed to pro­vide the agency with ad­di­tion­al de­tailed da­ta and the sta­tis­ti­cal analy­sis plan (‘SAP’) and an­tic­i­pates be­ing able to do so dur­ing the third quar­ter of 2021. Up­on re­ceiv­ing the FDA’s feed­back on these items, we ex­pect to move for­ward and re­quest a Type B pre-BLA meet­ing. Pend­ing a pos­i­tive Type B pre-BLA meet­ing, we aim to ini­ti­ate rolling re­sub­mis­sion of the om­bur­tam­ab BLA by the end of the year,” the New York-based biotech said in a state­ment.

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