Array BioPharma Advances To All Systems Go, Collects $85 Million
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Clinically Sound Investor
Array BioPharma: An Exciting Year Ahead
BPD Research • 11 Comments
BPD Research • 11 Comments
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.
May 14, 2015, 12:58 PM
- Micro cap Oncothyreon (ONTY +31.8%) jumps on a 6x surge in volume in another example of investors falling all over themselves to establish positions in companies that have submitted abstracts for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago, May 29 - June 2. Overeager punters are buying on news of positive study results, even from early-stage trials.
- In ONTY's case, the enthusiasm is in response to Abstract #602, which summarizes a Phase 1b study of ONT-380, a small molecule inhibitor of HER2, a growth factor rector that is over-expressed in cancers such as breast, ovarian and stomach. The company licensed it from Array BioPharma (ARRY -0.1%) in December.
- The study assessed the safety of the triplet regimen of ONT-380 + capecitabine + trastuzumab (Roche's Herceptin) as third-line therapy in patients with HER2+ metastatic breast cancer. Eight patients received two - eight cycles of treatment. The dosing regimen was well tolerated without causing grade 3 diarrhea. Preliminary efficacy was demonstrated by four partial responders, two with stable disease and two who progressed.
- Study results will be presented on the morning of May 30.
- Previously: Oncothyreon secures exclusive license to HER2 inhibitor (Dec. 12, 2014)
May 4, 2015, 12:45 PM
May 4, 2015, 9:16 AM
Jan. 23, 2015, 12:46 PM
Jan. 23, 2015, 9:11 AM
Dec. 12, 2014, 10:50 AM
- Array bioPharma (ARRY +0.8%) grants Oncothyreon (ONTY +5.3%) an exclusive license to develop, manufacture and commercialize the HER2 inhibitor ONT-380 (ARRY-380). The license replaces the co-development contract between the two firms.
- Under the terms of the license agreement, ONTY will pay ARRY a $20M upfront fee, a significant portion of any payments received from sublicensing the rights to ONT-380 and up to double-digit royalties on net sales. If ONTY is acquired within three years of the effective date of the agreement, ARRY will be eligible to receive up to $280M in commercial milestones.
- ONT-380 is an orally active, reversible and selective HER2 inhibitor invented at ARRY. In preclinical tumor models, it demonstrated dose-related tumor growth inhibition superior to Herceptin (trastuzumab) and Tykerb (lapatinib). ONTY is currently conducting two Phase 1b trials evaluating ONT-380 in combination with other agents.
Dec. 4, 2014, 7:37 AM
- Array BioPharma (NASDAQ:ARRY) is up 21% premarket in response to its regaining global rights to binimetinib.
- Previously: Array BioPharma to regain global rights to cancer therapy (Dec. 3, 2014)
Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
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
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