FDA hands Y-mAbs re­fusal to file let­ter in one of its pe­di­atric neu­rob­las­toma pro­grams

In what had looked like a promis­ing year for Y-mAbs Ther­a­peu­tics $YMAB as its two main neu­rob­las­toma pro­grams head­ed to the FDA, the com­pa­ny hit a road­block Mon­day af­ter­noon.

US reg­u­la­tors hand­ed the com­pa­ny an RTF for om­bur­tam­ab — the sec­ond of those two can­di­dates — cit­ing the need for more in­for­ma­tion on the man­u­fac­tur­ing and clin­i­cal mod­ules, Y-mAbs said. Al­though the com­pa­ny didn’t spec­i­fy what the agency re­quest­ed, Y-mAbs not­ed that it will be pro­vid­ing sup­ple­men­tary da­ta from a Phase II study re­gard­ing tu­mor re­sponse from the first 24 pa­tients in the tri­al.

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