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

By Chris Lange Updated Jan 12, 10:27AM EST · Published Jul 5, 9:50AM EDT

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

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%).

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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.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.