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Stock Market & Financial Investment News

News Breaks
August 3, 2014
18:56 EDTKKR, SNY, GSKPE firms mull combining older GSK, Sanofi drug brands, FT says
Private equity firms including KKR (KKR) and Warburg Pincus are considering purchasing the older drug portfolios of GlaxoSmithKline (GSK) and Sanofi (SNY) and combining them, says the Financial Times. Reference Link
News For GSK;SNY;KKR From The Last 14 Days
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July 24, 2015
15:27 EDTSNYEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTSNYRegeneron, 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.
14:44 EDTSNYEsperion 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 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
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14:20 EDTSNYFDA 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.
09:55 EDTKKRKKR enters bidding process for NCR, CNBC's Faber reports
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07:21 EDTSNYRegeneron, 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 EDTSNYRegeneron 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 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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July 23, 2015
07:08 EDTKKRKKR reports Q2 adjusted ENI 88c, consensus 62c
Reports Q2 revenue $255.87M, consensus $253.91M. Book value was $10.9B on a total reportable segment basis, or $12.77 per adjusted unit. Assets under management and fee paying assets under management totaled $101.6B and $83.7B, respectively, as of June 30, 2015. Return on equity and cash return on equity were 16.6% and 17.1%, respectively.
05:30 EDTKKRKKR, Borealis Maritime JV acquires Hanseatic Ship Asset Management
KKR and Borealis Maritime announced the $254.5M acquisition of Hanseatic Ship Asset Management GmbH, a 100% owned subsidiary of Commerzbank AG controlling a modern fleet of 18 container and dry cargo vessels, through a joint venture vehicle established by the two firms. Embarcadero Maritime III, a joint venture formed by KKR and Borealis Maritime to invest in distressed shipping assets, will acquire HSAM with all its assets. Following this purchase, investment vehicles established by KKR and Borealis will jointly operate a fleet of over 50 vessels in the container, chemical, product and LPG sectors. To date, KKR and Borealis have deployed over $600M into vessel acquisitions and continue to pursue additional transactions opportunistically.
July 21, 2015
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.
10:14 EDTKKRHigh option volume stocks:
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05:49 EDTKKRKKR files paperwork for an IPO of First Data, Financial Times reports
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05:37 EDTKKRKKR acquires 80% stake in Gestamp Solar
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July 20, 2015
06:15 EDTKKRKKR buys majority stake in Deutsche Glasfaser
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July 16, 2015
08:03 EDTGSKGlaxoSmithKline expects to ship 32M-38M flu vaccines over 2015-16 season
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July 15, 2015
05:57 EDTGSKGlaxoSmithKline, Francis Crick Institute to collaborate on range of new drugs
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July 14, 2015
13:01 EDTKKRFanDuel completes $275M funding round from KKR, Google Capital, Bloomberg says
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