Array BioPharma (NASDAQ:ARRY) increases the size of its public equity offering 15% to $115M, specifically 18.4M shares of common stock at $6.25.Underwriters over-allotment is an additional 2.76M shares. Closing date is October 3.
Net proceeds will fund R&D, the build-out of commercial capability, working capital and general corporate purposes.
Array BioPharma (NASDAQ:ARRY) eases 4% after hours on robust volume in response to its announcement that it has initiated a $100M public offering of common stock. Price, volume and terms have yet to be announced.
Update: On September 27, the company announced that it increased the size of its equity offering 15% to $115M, specifically 18.4M shares of common stock at $6.25.Underwriters over-allotment is an additional 2.76M shares. Closing date is October 3.
Net proceeds will fund R&D, the build-out of commercial capability, working capital and general corporate purposes. The close price on September 27 was $6.59.
Micro cap Array BioPharma (NASDAQ:ARRY) perks up 29% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial, COLUMBUS, assessing the combination of LGX818 (encorafenib) and MEK162 (binimetinib) for the treatment of patients with BRAF-positive, advanced, unresectable or metastatic melanoma.
The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to vemurafenib [Roche's (OTCQX:RHHBY) Zelboraf] alone. Specifically, median PFS for the combination was 14.9 months versus 7.3 months for vemurafenib (p<0.001).
Encorafenib is a BRAF inhibitor acquired from Novartis (NYSE:NVS) in early 2015. Binimetinib is a small molecule MEK inhibitor.
The company intends to file marketing applications as soon as feasible.
Array BioPharma (ARRY) reaches agreement with the FDA on the design of a Phase 3 clinical trial, BEACON CRC, assessing the combination of encorafenib and Eli Lilly's (LLY +0.3%) Erbitux (cetuximab), with or without binimetinib, in patients with BRAF-positive colorectal cancer (CRC) who have previously received first- or second-line systemic therapy.
BEACON CRC is an open-label study that will randomize 615 subjects 1:1:1 to receive either triplet therapy (encorafenib, Erbitux, binimetinib), doublet therapy (encorafenib, Erbitux) or control (irinotecan-based therapy and Erbitux). The primary endpoint is overall survival (OS) of the triplet therapy compared to control. Secondary endpoints will compare the efficacy of the doublet therapy to control and the triplet therapy to the doublet therapy, in addition to progression-free survival, objective response rate, duration of response, safety and tolerability. Patient enrollment should be completed in 2018.
Encorafenib is a BRAF inhibitor acquired from Novartis (NVX +0.8%) in early 2015. Cetuximab is an EGFR inhibitor. Binimetinib is a small molecule MEK inhibitor.
Micro cap Array BioPharma (NASDAQ:ARRY) is up 5% premarket on increased volume in response to its announcement that the FDA has accepted for review its New Drug Application (NDA) seeking approval of lead product candidate binimetinib for the treatment of advanced NRAS mutation-positive melanoma, a subgroup of melanoma associated with a poor prognosis. The agency's action date (PDUFA) is June 30, 2017.
Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. Array licensed binimetinib to Novartis (NYSE:NVS) in 2010 but reacquired the rights after Novartis purchased GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.