Array BioPharma’s New FDA Submissions Enough to Excite Investors?

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Array BioPharma Inc. (NASDAQ: ARRY) saw its shares were up handily in Wednesday’s premarket after the firm announced a critical submission to the U.S. Food and Drug Administration (FDA). Specifically, Array is submitting two New Drug Applications (NDAs) to support the use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

One real positive surrounding these submissions are that they are supported by data from the pivotal Phase 3 Columbus study. Ultimately this late-stage trial demonstrated that patients who received binimetinib and encorafenib had a significantly longer progression-free survival (PFS) compared to patients receiving vemurafenib.

The Columbus study recorded a PFS of 14.9 months, compared with 7.3 months observed with vemurafenib. In this study, COMBO450 was generally well-tolerated, however, grade 3/4 adverse events that occurred in more than 5% of patients receiving COMBO450 were increased blood creatine phosphokinase (9%), increased gamma-glutamyltransferase (7%) and hypertension (6%).

Ron Squarer, CEO of Array BioPharma, commented:

The totality of the Columbus results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints for this study. We look forward to working with the FDA as they review the NDA and, if approved, hope the combination of binimetinib and encorafenib will become a new option for patients with BRAF-mutant advanced melanoma.

Excluding Wednesday’s move, Array had underperformed the broad markets, with the stock down 1% year to date. However, over the past 52 weeks the stock is up about 140%.

Shares of Array traded down almost 2% at $8.54 shortly after Wednesday’s opening bell. The consensus analyst price target is $12.33 and a 52-week trading range is $3.10 to $13.40.