Array Biopharma Inc (NASDAQ:ARRY) fiscal second quarter revenues of $44.5 million handily surpass consensus view of $31 million. It intends to submit a New Drug Application with the FDA in this year for encorafenib plus binimetinib for BRAF-positive melanoma.
The financial performance
Revenue for 2Q2017 surged $9.1 million as against to the same quarter of FY2016. The increase was mainly due to earning an achievement from Loxo Oncology for the development of larotrectinib, the TRK inhibitor for cancer and an achievement from Roche for the development of danoprevir. Cost of associated programs increased $3.4 million paralleled to 2Q2016. The increase was largely due to expenses incurred on the BEACON CRC study.
R&D cost increased $5.1 million as against to 2Q2016. The jump was due to encorafenib and binimetinib expenses as they transitioned activity from the contracts with Novartis. Net loss for the reported quarter of fiscal 2017 came at ($0.14) per share compared to ($0.17) per share, for the second quarter in FY2016.
The phase 1 study report of SELUMETINIB in pediatric patients with NF1 and plexiform neurofibromas was issued in the New England Journal of Medicine. Children with the plexiform neurofibromas and NF1, tolerated selumetinib and, in most instances, responded with tumor shrinkage. NF1 impacts 1 in 3,000 people. The trial report was issued in December 2016.
Array reported that selumetinib is being assessed as a treatment alternative in registration-enabling trials in patients with NF1 and subjects with differentiated thyroid cancer. It licensed exclusive global rights to selumetinib to AstraZeneca and will receive future potential royalties and milestones on product sales.
The primary objective of this clinical study was to assess the safety and toxicity of selumetinib in people with inoperable plexiform neurofibromas and NF1, and, encouragingly, a big percentage of the selumetinib-linked toxic effects were mild. Currently, no therapies are stated effective for NF1-linked large plexiform neurofibromas, however, in this study, partial responses, meaning 20% or more decline in tumor volume, were noted in over 70% of the patients.
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