Array Rises On Binimetinib Data, 2016 Regulatory Submissions
This article was originally published in Scrip
Array Biopharma gained 20.6% to close at $4.62 per share on Dec. 16 after the company said it will seek regulatory approvals for binimetinib based on results from the Phase III NEMO clinical trials, which showed the MEK inhibitor nearly doubled median progression-free survival (PFS) for NRAS-mutant melanoma patients to 2.8 months versus 1.5 months for dacarbazine (p<>
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Following a meeting with the US FDA, Array BioPharma has withdrawn the NDA for its MEK inhibitor binimetinib because of insufficient evidence of clinical benefit in a tough-to-treat subgroup of melanoma patients, that may lead to a rethink of its commercialization strategy.
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