Array BioPharma Inc. (NASDAQ: ARRY) is watching its shares make a handy gain on Friday after making a key U.S. Food and Drug Administration (FDA) submission. The company announced the submission of a New Drug Application (NDA) for binimetinib in patients with advanced NRAS-mutant melanoma to the FDA. The submission is based on results of the pivotal Phase 3 NEMO (NRAS MELANOMA AND MEK INHBITOR) study, which found binimetinib significantly extended median progression-free survival (PFS), the study’s primary endpoint, as compared with dacarbazine.
Separately, Binimetinib demonstrated significant improvement in overall response rate (ORR) and disease control rate (DCR). While there was no statistically significant difference demonstrated in overall survival, the median overall survival (mOS) favored the binimetinib arm.
The candidate was generally well-tolerated and the adverse events (AEs) reported were consistent with previous results in NRAS-mutant melanoma patients.
Ron Squarer, CEO of Array BioPharma, commented:
The new drug application for binimetinib represents Array’s first – an important milestone for this promising compound and our Company. NRAS-mutant melanoma represents an often overlooked subset of advanced disease without meaningful treatment options beyond immunotherapy and NEMO is the first-ever trial to meet a PFS endpoint in this population. We look forward to working with the FDA as they evaluate our application and the potential for binimetinib as a treatment option for these patients.
Shares of Array closed Thursday up 2% at $3.56, with a consensus analyst price target of $8.29 and a 52-week trading range of $2.38 to $7.24. Following the announcement, the stock was up over 7% at $3.83 in early trading indications Friday.