Array BioPharma Advances To All Systems Go, Collects $85 Million
Clinically Sound Investor
Clinically Sound Investor
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.
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)
Fri, Apr. 1, 10:00 AM
- Array BioPharma (ARRY -3.7%) slumps on increased volume in response to its announcement that it has terminated its Phase 3 study, MILO, assessing binimetinib in low-grade ovarian cancer due to lack of efficacy. Detailed results will be shared with the scientific community at a later date.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is being investigated in BRAF-positive (COLUMBUS study) and NRAS-positive (NEMO study) melanoma.
- Array licensed binimetinib to Novartis (NVS -2.3%) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (GSK -1.7%) oncology business in early 2015.
- Now read Earnings Peek: Array BioPharma Has A Lot Going On And A Lot of Money
Fri, Apr. 1, 9:17 AM
Dec. 16, 2015, 12:45 PM
Dec. 16, 2015, 9:14 AM
Dec. 16, 2015, 7:55 AM
- Array BioPharma (NASDAQ:ARRY) jumps 28% premarket on robust volume in response to its announcement of successful results in a 402-subject Phase 3 clinical trial, NEMO, assessing lead product candidate binimetinib in patients with advanced NRAS-positive melanoma, a type of skin cancer associated with a poor prognosis. The study met its primary efficacy endpoint of improving progression-free survival (PFS) compared to the chemo drug dacarbazine. Patients treated with binimetinib experienced a median PFS of 2.8 months versus 1.5 months for dacarbazine (p<0.001).
- Binimetinib was generally well-tolerated and the adverse events were consistent with earlier studies in NRAS-positive melanoma patients.
- The company plans to submit marketing applications for this group of patients in H1 2016.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is also being investigated in ovarian cancer (MILO study) and BRAF-positive melanoma (COLUMBUS study).
Aug. 3, 2015, 9:18 AM
Jul. 22, 2015, 9:16 AM
Jul. 22, 2015, 8:16 AM
- A Phase 3 clinical trial (SUMIT) assessing AstraZeneca's (NYSE:AZN) Orphan Drug-tagged selumetinib in combination with dacarbazine for the treatment of uveal melanoma failed to achieve its primary endpoint of progression-free survival (PFS). The full analysis of the data is ongoing.
- Selumetinib, licensed from Array BioPharma (NASDAQ:ARRY) in 2003, is under development for the second-line treatment, in combination with docetaxel, of KRAS-positive advanced non-small cell lung cancer, differentiated thyroid cancer and neurofibromatosis Type 1. It inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from growing.
- Uveal melanoma (UM), comprising 5% of all melanoma cases, occurs when cancer cells grow in the tissues of the eye. No effective treatments for advanced UM exist.
- AZN shares are off a fraction premarket on light volume. ARRY is off 15% premarket on higher-than-normal volume.
Array BioPharma Inc. is a biopharmaceutical company, which focuses on the discovery, development, and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Its proprietary drug development pipeline focuses on the treatment of cancer and inflammatory disease... More
Industry: Research Services
Country: United States