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April 3, 2014
06:28 EDTREGN, CELGAtopic dermatitis could bring upside to Regeneron, Celgene, says Citigroup
Citigroup believes Regeneron's (REGN) dupilumab and Celgene's (CELG) Otezla for atopic dermatitis are being overlooked by investors and could provide upside for both names. Citi believes both drugs have good efficacy but adds that dupilumab is more advanced. The firm has a Buy rating on both stocks.
News For REGN;CELG From The Last 14 Days
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January 28, 2015
15:38 EDTCELGNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Celgene (CELG), consensus 99c... ConocoPhillips (COP), consensus 59c... Abbott Laboratories (ABT), consensus 67c... Occidental Petroleum (OXY), consensus 68c... Colgate-Palmolive (CL), consensus 74c... Ford (F), consensus 23c... Dow Chemical (DOW), consensus 69c... Alibaba (BABA), consensus 75c... Thermo Fisher (TMO), consensus $1.94; Time Warner Cable (TWC), consensus $2.09... Phillips 66 (PSX), consensus $1.34... Alexion Pharmaceuticals (ALXN), consensus $1.29... Baxter International (BAX), consensus $1.31... Cardinal Health (CAH), consensus $1.10... Raytheon (RTN), consensus $1.08... Northrop Grumman (NOC), consensus $2.25... Viacom (VIAB), consensus $1.28... Valero Energy (VLO), consensus $1.32... Sherwin-Williams (SHW), consensus $1.38... Hershey (HSY), consensus $1.06... Mead Johnson (MJN), consensus 88c... Zimmer (ZMH), consensus $1.71... Xcel Energy (XEL), consensus 34c... Royal Caribbean (RCL), consensus 42c... Coach (COH), consensus 66c... Kate Spade (KATE), consensus 24c... Harley-Davidson (HOG), consensus 34c... Stanley Black & Decker (SWK), consensus $1.52... L-3 Communications (LLL), consensus $2.27... JetBlue (JBLU), consensus 24c.
January 26, 2015
05:14 EDTREGNRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
07:39 EDTREGNRegeneron announces EYLEA Injection recommended for approval in EU
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07:21 EDTCELGCelgene receives positive CHMP opinion for ABRAXANE
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January 21, 2015
10:16 EDTREGNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
08:36 EDTCELGCelgene price target raised to $139 from $115 at RW Baird
Baird raised its price target on Celgene to $139 from $115 following last week's guidance from the company. Baird reiterated its Outperform rating on Celgene shares.
January 16, 2015
09:11 EDTCELGCelgene says oral Otezla approved by European Commission in 2 indications
Celgene International, a wholly-owned subsidiary of Celgene Corporation, announced that the European Commission has granted marketing authorisation for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, in two therapeutic indications: For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light. Alone or in combination with Disease Modifying Antirheumatic Drugs, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The marketing authorization is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis and psoriatic arthritis treated with OTEZLA through 52 weeks, across multiple endpoints. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2014.12 OTEZLA will be launched in the European Union in the coming months in accordance with local requirements.
January 15, 2015
07:59 EDTCELGAmerican Society of Clinical Oncology to hold a symposium
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