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Stock Market & Financial Investment News

News Breaks
April 3, 2014
06:28 EDTCELG, REGNAtopic 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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July 24, 2015
14:20 EDTREGNFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
14:06 EDTREGNRegeneron trading halted, pending news
08:45 EDTREGNRegeneron cholesterol treatment likely to be approved today, says Bernstein
Bernstein notes that today is the PDUFA day for Regeneron's (REGN) and Amgen's (AMGN) Praluent, which would be the first antibody approved for cholesterol treatment in the U.S. The firm expects the drug to be approved today. After surveying doctors on the drug, Bernstein finds that their attitudes towards it are "remarkably positive." The firm keeps an Outperform rating on Regeneron and a Market Perform rating on Amgen.
08:08 EDTCELGCelgene price target raised to $190 from $156 at Canaccord
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07:21 EDTREGNRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTREGNRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTREGNFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
19:50 EDTCELGCelgene price target raised to $163 from $146 at Cantor
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10:50 EDTCELGCelgene positioned for sustainable growth, says Piper Jaffray
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07:37 EDTCELGCelgene reports Q2 Revlimid sales up 19% to $1.44B
ABRAXANE® sales for the second quarter were $244 million, a 13 percent increase. POMALYST®/IMNOVID® sales for the second quarter were $235 million, an increase of 46%. VIDAZA® sales in the second quarter remained flat year-over-year at $152 million. OTEZLA® sales for the second quarter were $90 million, increasing 49 percent over the first quarter of 2015.
07:37 EDTCELGCelgene raises FY15 adjusted EPS view to $4.75-$4.85 from $4.60-$4.75
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07:32 EDTCELGCelgene reports Q2 adjusted EPS $1.23, consensus $1.20
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July 22, 2015
15:26 EDTCELGNotable companies reporting before tomorrow's open
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10:01 EDTREGNOn The Fly: Analyst Initiation Summary
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09:28 EDTCELGBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
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08:39 EDTREGNRegeneron initiated with a Market Perform at Northland
Northland analyst James Kuo started shares of Regeneron Pharmaceuticals with a Market Perform rating and $500 price target. Pointing out that shares are up 34% year-to-date and 80% year-over-year, Kuo prefers to watch the upcoming launch of Praluent from the sidelines.
July 21, 2015
12:47 EDTREGNPiper 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.
11:03 EDTCELGCelgene treatment of pediatric Crohn's disease receives FDA orphan designation
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06:29 EDTCELGCelgene price target raised to $160 from $147 at Piper Jaffray
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06:24 EDTCELGPiper expects 'stronger, bolder' move from Biogen
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