Sev­er­al weeks af­ter get­ting hit with an RTF, Y-mAbs lands ap­proval for its oth­er neu­rob­las­toma can­di­date

Near­ly two months af­ter hand­ing Y-mAbs a re­fusal to file let­ter for one of its main neu­rob­las­toma can­di­dates, the FDA gave the biotech an ac­cel­er­at­ed OK for the oth­er — but with a box warn­ing.

Y-mAbs, which flew most­ly un­der the radar un­til a few years ago, snagged ap­proval for naxi­ta­m­ab as a sec­ond-line treat­ment in com­bi­na­tion with gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF). Pa­tients old­er than 1 year old can take the drug for re­lapsed or re­frac­to­ry high-risk neu­rob­las­toma in the bone or bone mar­row. The good news cush­ioned last month’s blow, send­ing the com­pa­ny’s stock $YMAB — which sank more than 18% up­on news of the RTF — up 10.15% as of Mon­day morn­ing.

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