Ar­ray walks back its FDA pitch on binime­tinib, de­rail­ing plans for com­mer­cial launch

Ar­ray Bio­Phar­ma has some ex­plain­ing to do. Fif­teen months af­ter the Boul­der, CO-based biotech said that it had the da­ta need­ed for its first ap­proval of binime­tinib for NRAS-pos­i­tive melanoma, ex­ecs are walk­ing back the ap­pli­ca­tion and its plans for a launch.

In a state­ment out Sun­day evening, Ar­ray $AR­RY said that af­ter get­ting feed­back from the FDA, ex­ecs  “con­clud­ed that the clin­i­cal ben­e­fit demon­strat­ed in the Phase 3 NEMO clin­i­cal tri­al would not be found suf­fi­cient to sup­port ap­proval of the NRAS-mu­tant melanoma NDA.”

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