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Stock Market & Financial Investment News

News Breaks
July 23, 2014
06:41 EDTNVS, ARRYArray BioPharma shares attractive at current levels, says Piper Jaffray
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
News For ARRY;NVS From The Last 14 Days
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February 12, 2016
16:09 EDTNVSNovartis reports 5.57% stake in Arrowhead
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February 11, 2016
07:17 EDTNVSLeerink to hold a conference
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05:35 EDTNVSSandoz reports EMA acceptance of MAA for biosimilar pegfilgrastim
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency, or EMA, has accepted their Marketing Authorization Application, or MAA, for its biosimilar to Amgen's EU-licensed Neulasta - a long-acting recombinant human granulocyte colony-stimulating factor, or G-CSF. Sandoz is seeking approval for the same indication as the reference product.
February 9, 2016
11:18 EDTNVSOptions with increasing call volume; CERS WYN NVS ZIOP PZM PI OC DB MLM
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February 8, 2016
09:38 EDTNVSCigna enters into outcomes-based contract with Novartis
Cigna (CI) has entered into an outcomes-based contract with the pharmaceutical company Novartis (NVS) for the drug Entresto, which was approved by the FDA for the treatment of heart failure with reduced ejection fraction. The pay-for-performance agreement ties the financial terms to how well the drug improves the relative health of Cigna's customers. The primary metric is reduction in the proportion of customers with heart failure hospitalizations. This agreement is effective for Cigna's commercial business. Entresto is a preferred brand subject to prior authorization review. The prior authorization process is part of utilization management to help control prescription drug costs and ensure coverage of the most appropriate drug therapies.
06:28 EDTNVSPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 7, 2016
14:27 EDTNVSNovartis' somatic cell therapy receives orphan designation
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February 4, 2016
07:23 EDTNVSGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 2, 2016
11:14 EDTNVSNovartis management to meet with Jefferies
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07:42 EDTNVSPressure mounts on big pharma names to shrink, sharpen focus, FT says
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07:03 EDTARRYArray BioPharma plans to submit binimetinib for marketing approval in 1H16
In December 2015, Array reported top-line results from the ongoing Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival compared with dacarbazine treatment, with a hazard ratio of 0.62, [95% CI 0.47-0.80] and a p-value of less than 0.001. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm. In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients. Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical conference in 2016. In addition, Array expects top-line results from Part 1 of the COLUMBUS trial in the first half of 2016 and projects a regulatory filing of binimetinib and encorafenib in 2016. In October 2015, Part 2 of COLUMBUS achieved its target patient enrollment. The MILO Phase 3 study in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates enrollment to be complete in 2016 with the availability of top-line data, along with a projected regulatory filing, in 2017. Based on the strength of the Phase 2 combination data with encorafenib in patients with BRAF-mutant colorectal cancer shared at the 2015 European Society of Medical Oncology's (ESMO) World Congress of Gastrointestinal Cancer, Array plans to initiate a Phase 3 global registration trial in that patient population in 2016.
07:03 EDTARRYArray BioPharma reports Q2 EPS (17c), consensus (6c)
Reports Q2 revenue $35.43M, consensus $32.7M.
February 1, 2016
11:57 EDTARRYDana-Farber, Array BioPharma to collaborate on immuno-oncology research
Dana-Farber Cancer Institute announced announced an immuno-oncology collaboration with potential applicability in a wide range of oncology indications with Array BioPharma. The research team at Dana-Farber's Robert and Renee Belfer Center for Applied Cancer Science will work with Array scientists on novel immune-oncology targets with the goal of bringing innovative medicines to patients. The collaboration will leverage the Belfer Center's proprietary immuno-oncology platform. Combining Dana Farber's oncology expertise with the Array's proficiency in drug discovery provides a unique opportunity to accelerate drug discovery of effective medicines for patients with unmet medical need.

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