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News Breaks
February 11, 2014
06:38 EDTREGNRegeneron reports Q4 EPS $2.24, may not compare to consensus 98c
Reports Q4 revenue $610.41M, consensus $580.47M.
News For REGN From The Last 14 Days
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July 27, 2015
10:45 EDTREGNEsperion price target lowered to $40 from $55 at Chardan
Chardan analyst Gbola Amusa earlier today lowered his price target for Esperion Therapeutics (ESPR) to $40 saying the label for Regeneron's (REGN) Praluent label "reveals multiple negatives" for the company. The FDA has had a policy change by not approving broad use for Praluent, Amusa told investors in a research note. He adds that Esperion's ETC-1002's add-on LDL-lowering ability is "much more modest" than Praluent. The analyst says he has increased conviction in his Sell rating on Esperion.
08:22 EDTREGNNews reports on Regeneron Praluent label inaccurate, says RBC Capital
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08:19 EDTREGNRegeneron drug price well above estimate, says Leerink
Leerink points out the $14,600 annual price for Regeneron's Praluent is well above its estimate of $5,000. The firm says the broad label and price make Praluent a $15B opportunity in the U.S. It reiterates an Outperform rating on Regeneron.
07:40 EDTREGNEsperion price target lowered to $120 from $130 at Citi
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July 24, 2015
16:00 EDTREGNRegeneron, Sanofi say the U.S. WAC price of Praluent is $40 per day
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15:41 EDTREGNRegeneron reopens, down 1.8% to $546.61 after FDA approves Praluent
15:35 EDTREGNRegeneron to resume trading at 3:40 pm ET
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15:27 EDTREGNEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTREGNRegeneron, Sanofi's cholesterol treatment Praluent gets FDA approval
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration approved Praluent Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses- 75 mg and 150 mg. Both doses of Praluent are available in a single 1 milliliter injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks. The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost. The U.S. WAC price of Praluent is $40 per day, $1,120 every 28 days, for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.
15:00 EDTREGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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14:44 EDTREGNEsperion slides after FDA assigns indication for rival cholesterol drug
Shares of Esperion Therapeutics (ESPR), a drug company focused on LDL-cholesterol lowering therapies, are sharply lower in afternoon trading after the FDA granted approval for the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. WHAT'S NEW: This afternoon, the FDA announced the approval of Praluent injection, which is a PCSK9 drug marketed by Sanofi (SNY) and Regeneron (REGN). 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, the FDA indicated. The drug, like Esperion's ETC-1002, seeks to lower patients' cholesterol. PRICE ACTION: In afternoon trading, Esperion shares are down 12% to $84.21. The stock spiked as low as $81.50 immediately after the FDA made its announcement regarding Praulent. Meanwhile, Sanofi shares are fractionally higher and Regeneron shares are halted.
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.
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 22, 2015
10:01 EDTREGNOn The Fly: Analyst Initiation Summary
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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.
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