There’s a new FDA-approved melanoma medication on the scene. Today, the U.S. regulators green-lighted Array Biopharma’s (NASDAQ:ARRY) melanoma combo drug (binimetinib/encorafenib). The approval came a few days ahead of the PDUFA of June 30th.
Array CEO Ron Squarer commented, “We are thrilled with the approval of BRAFTOVI + MEKTOVI, which help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer […] As presented at ASCO, BRAFTOVI + MEKTOVI is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase 3 trial. These products represent a new standard of care for BRAF-mutant melanoma patients and we sincerely thank the patients and dedicated researchers who participated in our clinical program.”
In reaction, Cantor analyst Mara Goldstein reiterates an Overweight rating on Array shares, with a price target of $26, which represents a potential upside of 38% from where the stock is currently trading. (To watch Goldstein’s track record, click here)
Goldstein commented, “Approval was expected, in our view, based on efficacy, safety and lack of FDA AdCom review. The drug is now available to order through selected pharmacies as per ARRY’s press release […] We expect a label update with COLUMBUS’ median OS of 33.6 months (was not mature at the time of review), based on prior ARRY’s correspondence with FDA […] Key moving pieces in BRAF+ melanoma likely to be commercial headwind (NVS’s (Not Covered) MEK/BRAF combo) and unknown optimal treatment sequencing/checkpoint inhibitors, but with a best in class profile, in our view, we see the potential for ARRY to gain market share.”
“We see upside in the shares being driven by the BEACON-CRC program, where the company is likely to pursue an accelerated strategy given the recently released impressive OS data from the safety lead in (SLI) of the Phase III trial,” the analyst concluded.
How does Goldstein’s bullish forecast echo against the word of the Street? Quite positively, as TipRanks analytics exhibit ARRY as a Strong Buy. Based on 6 analysts polled in the last 3 months, all 6 are bullish on Array stock. The 12-month average price target stands at $21.80, marking a nearly 22% upside from where the stock is currently trading.