FDA Accepts Array BioPharma's NDA For Its Binimetinib

Array BioPharma Inc ARRY revealed that the FDA has accepted its New Drug Application (NDA) for its binimetinib. The company indicated that a target action date has been fixed for June 30 next year under the Prescription Drug User Fee Act.

Based on findings from the pivotal final stage NEMO study in patients with NRAS-mutant melanoma, Array indicated that it completed its NDA submission of binimetinib in late June. As part of the review process, the medical regulator would hold an advisory committee meeting.

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Commenting the developments, the company's Chief Medical Officer, Victor Sandor, said, "There are very few treatment advances beyond immunotherapy for this devastating disease, which impacts one out of five advanced melanoma patients. Binimetinib is the first and only MEK inhibitor to demonstrate improvement on progression free survival in a Phase 3 trial for NRAS mutant melanoma patients."

Following the news, the stock traded up by $0.30, or 8.7 percent, to $3.73 in the pre-market trading on Thursday.