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August 21, 2014
05:42 EDTSNY, AZN, JNJ, ILMNIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
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July 22, 2015
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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10:01 EDTILMNOn The Fly: Analyst Downgrade Summary
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09:07 EDTAZNOn The Fly: Pre-market Movers
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08:58 EDTILMNIllumina weakness a buying opportunity, says Cowen
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07:52 EDTILMNIllumina downgraded to Neutral from Buy at Janney Capital
07:44 EDTILMNIllumina price target lowered to $250 from $275 at Canaccord
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05:45 EDTILMNIllumina should be bought on post-earnings selloff, says Mizuho
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 21, 2015
19:00 EDTILMNOn The Fly: After Hours Movers
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16:24 EDTILMNIllumina drops sharply after results
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16:16 EDTILMNIllumina reports Q2 cash flow from operations of $171M, free cash flow $130M
16:15 EDTILMNIllumina reports Q2 gross margin 69.8% vs. 67.1% a year ago
16:15 EDTILMNIllumina raises FY15 adjusted EPS view to $3.39-$3.45 from $3.36-$3.42
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16:13 EDTILMNIllumina reports Q2 adjusted EPS 80c, consensus 77c
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15:02 EDTILMNNotable companies reporting after market close
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12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
July 20, 2015
06:17 EDTILMNMizuho sees Q2 earnings beats in Diagnostics space
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July 17, 2015
10:05 EDTILMNOn The Fly: Analyst Initiation Summary
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06:55 EDTILMNIllumina initiated with a Buy at Canaccord
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