Array Walks Back Its FDA Pitch on Binimetinib, Derailing Plans for Commercial Launch

Excerpt:

“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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