Array (ARRY) Oncology Drug Accepted For Review In The U.S.

Array BioPharma (NASDAQ:ARRY) announced that the FDA has accepted a New Drug Application (NDA) for its pipeline candidate, binimetinib.

The NDA was submitted in Jun 2016 based on positive results from the phase III trial, NEMO, which compared binimetinib with dacarbazine in unresectable or metastatic NRAS-mutant melanoma patients. The study met its primary endpoint of improving progression-free survival (PFS), compared with dacarbazine treatment.

The FDA has given a Prescription Drug User Fee Act (PDUFA) of Jun 30, 2017. As part of the review process, the agency plans to hold an advisory committee meeting.

We note that Array is currently preparing for an Application Orientation Meeting with the FDA scheduled for Sep 2016. The company plans to discuss the NDA package with the regulatory agency, including the candidate’s clinical risk/benefit profile, at the meeting.

We remind investors that Array regained development and commercialization rights to binimetinib from Novartis Pharma AG (NYSE:NVS) in Mar 2015.

Thereafter, the company entered into a an agreement with Pierre Fabre Medicament SAS, whereby the latter was granted rights to commercialize binimetinib and encorafenib in all countries except the U.S., Canada, Japan, Korea and Israel, where Array retained rights. The agreement became effective in Dec 2015.

Array BioPharma is focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients suffering from cancer. Five registration studies on three cancer candidates – binimetinib (MEK162), encorafenib (LGX818) and selumetinib – are currently underway at the company.

Meanwhile, Array is evaluating binimetinib in several other oncology trials. A phase III trial, COLUMBUS, is evaluating encorafenib, in combination with binimetinib, in patients with BRAF-mutant melanoma. It has also initiated the BEACON trial to study encorafenib, in combination with binimetinib and cetuximab, in patients with BRAFV600E-mutant colorectal cancer. Top-line data from the COLUMBUS trial will be out in the third quarter of 2016.

Array BioPharma currently carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks include Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) , and Corcept Therapeutics Incorporated (NASDAQ:CORT) . Both these stocks sports a Zacks Rank #1 (Strong Buy).

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