Array Biopharma Inc’s (ARRY) BRAF-Mutant Melanoma Combo Treatment Gets a PDUFA Date; Cantor Chimes In

Analyst expected NDA acceptance- but believes the FDA news importantly lowers regulatory risk for ARRY.

Array Biopharma Inc (NASDAQ:ARRY) investors are jumping for joy after hearing the good news that the FDA is taking the drug maker’s one-two combination punch of binimetinib (bini) and encorafenib (enco) for review in treating BRAF-mutant metastatic melanoma. Shares today are on an almost 5% upswing with optimism resting on ARRY’s PDUFA date for the NDA come June 30th of next summer. Considering the Agency’s interim review, an Ad Com meeting is not presently expected on bini and enco’s path to approval.

Cantor analyst Mara Goldstein is three cheers and bullish on the stock’s prospects, noting that “Although we anticipated acceptance of the NDA, the formal notice and preliminary review results does reduce regulatory risk, in our view.” Especially following this weekend’s encouraging data updates at the European Society for Medical Oncology Congress in Madrid, market potential expansion is on ARRY’s side, says Goldstein, who takes better tolerability and progression-free survival results as good indications for Array’s chances to succeed.

As such, the analyst reiterates an Overweight rating on ARRY stock with a price target of $15, which represents a nearly 44% upside from where the stock is currently trading. (To watch Goldstein’s track record, click here)

Today’s FDA step forward “follows strong data presentations at ESMO, which included additional data from the COLUMBUS Part II trial, and preliminary data from the safety portion of the BEACON CRC trial,” highlights Goldstein, who adds, “BEACON, in our view, is an opportunity to expand the market potential of bini/enco, and the preliminary results showing improved tolerability and PFS above other regimens is a positive sign, in our view.”

Overall, “We believe the bini/enco combination demonstrates best-in-class treatment for melanoma, in addition to emerging data suggesting a role in BRAF-mutant colorectal cancer,” surmises the analyst.

Golstein will not be the only bull singing the biotech firm’s praises today, as TipRanks analytics indicate ARRY as a Strong Buy. Out of 6 analysts polled by TipRanks in the last 3 months, all 6 are bullish on Array stock. With a return potential of 31%, the stock’s consensus target price stands at $13.67.

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