Array BioPharma Advances To All Systems Go, Collects $85 Million
Clinically Sound Investor
Clinically Sound Investor
Wed, Sep. 14, 11:27 AM
- 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.
Thu, Sep. 1, 9:24 AM
Thu, Sep. 1, 8:39 AM
- 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.
Tue, Aug. 30, 9:12 AM
- Micro cap Array BioPharma (NASDAQ:ARRY) perks up 7% premarket on increased volume in response to its announcement of positive results in a Phase 2 clinical trial assessing ARRY-797 for the treatment of patients with lamin A/C-related dilated cardiomyopathy (LMNA-DCM), a rare degenerative cardiovascular disease caused by mutations in the LMNA gene that is associated with a poor prognosis. The data were presented at the European Society of Cardiology Congress in Rome.
- All patients in the open-label study had stable New York Heart Association class II-IIIa heart failure and eleven had an implanted cardiac defibrillator. They were randomized to receive either 100 mg or 400 mg of ARRY-797 twice daily for 12 weeks. All were also receiving multiple heart failure medications.
- The mean change from baseline in the six-minute walk test (6MWT), the primary endpoint, was 69 meters. Sustained improvement in related biomarkers was also observed. A trend for greater improvement was seen with the 400 mg dose.
- ARRY-797 is an oral p38 mitogen-activated protein kinase (MAPK) inhibitor. The genetic mutations in LMNA-DCM lead to a loss of functional lamin proteins that activates the p38 MAPK pathway which leads to cardiac cell death and cardiac tissue remodeling (changes in the heart's size, structure and physiology). This degrades the performance of the heart over time and eventually leads to failure. Inhibiting MAPK can potentially reverse cardiac remodeling and improve heart function.
- The company has met with regulators to discuss the design of a pivotal study to support a marketing application. It is also evaluating its options for development, including partnering, creating a separate company focused solely on the asset or advancing it on its own.
Thu, Aug. 18, 5:35 PM
Tue, Aug. 9, 12:46 PM
Tue, Aug. 9, 11:00 AM
Tue, Aug. 9, 9:19 AM
Tue, Aug. 9, 8:36 AM
- Array Biopharma (NASDAQ:ARRY) -11.2% premarket following AstraZeneca's news that the Phase 3 trial of a treatment for lung cancer failed to meet its primary endpoint.
- The trial of ARRY's MEK inhibitor elumetinib, in combination with docetaxel chemotherapy as a second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer, failed to meet its goal of progression-free survival and did not have a significant effect on overall survival.
- AZN acquired exclusive worldwide rights to selumetinib from ARRY, which has received $26.5M in up-front and milestone payments and is entitled to ~$70M in potential additional development milestone payments and royalties on product sales.
Thu, Aug. 4, 8:09 AM
Wed, Aug. 3, 5:30 PM
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Fri, Jul. 1, 9:13 AM
Thu, Jun. 30, 5:37 PM
Thu, Jun. 30, 4:18 PM
- Array BioPharma (NASDAQ:ARRY) files a New Drug Application (NDA) with the FDA seeking approval of lead product candidate binimetinib for the treatment NRAS mutation-positive melanoma. The principal data supporting the application was generated in the Phase 3 NEMO study which showed an improvement in progression-free survival versus the chemo agent dacarbazine.
- 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 acquired GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.
- Previously: Array Bio's lead product candidate successful in late-stage melanoma study; shares up 28% premarket (Dec. 16, 2015)
Tue, May 3, 8:09 AM
Mon, May 2, 5:30 PM
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