Array BioPharma Rallies on Late-Stage Win

Array BioPharma Inc. (NASDAQ: ARRY) led the bulls early on Monday on news of a positive late-stage clinical trial. The company reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment.

In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.

Binimetinib is also being studied in the Phase 3 Columbus trial for patients with BRAF-mutant melanoma and the Phase 3 Milo trial for patients with low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.

Ron Squarer, CEO of Array BioPharma, said:

We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma. We look forward to discussing the data with the FDA and other regulatory agencies in the near future.

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Keith T. Flaherty, M.D., Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital, added:

The presence of an NRAS mutation is a poor prognostic indicator for patients with advanced melanoma. I am encouraged the NEMO trial met its primary endpoint and look forward to sharing the full results soon. As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition in this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy.

Shares of Array closed Tuesday down 0.5% at $3.83, with a consensus analyst price target of $10.33 and a 52-week trading range of $3.72 to $8.59. Following the release of the results, the stock was up 20% at $4.60 in early trading indications Wednesday.