Array BioPharma ($ARRY) announced that it has withdrawn its New Drug Application (NDA) in the U.S. seeking approval of binimetinib for the treatment of NRAS mutation-positive melanoma, a rare subtype of skin cancer. The company took the decision upon receiving feedback from the FDA that concluded that data from the Phase 3 NEMO study was not sufficient to demonstrate a clinical benefit. However, it plans to continue the development for other indications.
Array stock has shown strong performance this year as it gained 14 percent this year so far. In the past 12 months, the price has appreciated over 274 percent. The news of withdrawal sent the stock price tumbling. However, it is likely that the stock will resume its upward movement as the company still plans to file for combination therapy involving binimetinib with encorafenib for treating BRAF-mutated melanoma in 2017.
The company also recently announced its quarterly results. Its revenue or the second quarter of fiscal 2017 was $44.5 million, compared to $39.3 million for the prior sequential quarter. Its quarterly net loss stood at $23.3 million, or ($0.14) per share, and was $28.6 million, or ($0.20) per share in the prior quarter. Array’s cash, Cash Equivalents and Marketable Securities as of December 31, 2016 were $214.8 million including net proceeds of $124.2 million from the public offering of 21,160,000 shares of the company’s common stock in October 2016.