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Stock Market & Financial Investment News

News Breaks
December 16, 2012
21:40 EDTWDC, REGN, EQIX, ADI, VRSK, LMCA, DISCA, SBAC, LBTYA, CTRXStocks being added to the NASDAQ-100 Index in annual re-ranking
The NASDAQ OMX Group announced the results of the annual re-ranking of the NASDAQ-100 Index, which will become effective prior to market open on Monday, December 24. The following ten securities will be added to the Index: Analog Devices, Inc. (ADI), Catamaran Corporation (CTRX), Discovery Communications (DISCA), Equinix, (EQIX), Liberty Global (LBTYA), Liberty Media Corporation (LMCA), Regeneron Pharmaceuticals (REGN), SBA Communications Corporation (SBAC), Verisk Analytics(VRSK) and Western Digital Corporation (WDC).
News For ADI;CTRX;DISCA;EQIX;LBTYA;LMCA;REGN;SBAC;VRSK;WDC From The Last 14 Days
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July 27, 2015
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 23, 2015
10:00 EDTWDCOn The Fly: Analyst Downgrade Summary
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06:29 EDTWDCWestern Digital downgraded to Equal Weight from Overweight at Morgan Stanley
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July 22, 2015
14:51 EDTADIEarnings Watch: Qualcomm reports after speculations of potential breakup
Qualcomm (QCOM) is expected to report third quarter earnings after the close on July 22, with a conference call scheduled for 4:45 pm ET. Qualcomm is a maker of semiconductors and telecommunications equipment. EXPECTATIONS: Analysts are looking for earnings per share of 95c on revenue of $5.85B. EPS consensus ranges 90c-$1.05 on a revenue range of $5.59B-$6.08B, according to First Call. LAST QUARTER: On April 22, Qualcomm reported Q2 EPS of $1.40 against expectations for $1.33, and revenue of $6.89B versus estimates of $6.83B. The company also cut its FY15 EPS guidance to $4.60-$5.00 from $4.85-$5.05 and lowered projected revenue to $25B-$27B from $26.3B-$28B, saying it expects pressure in its semiconductor business due to customer shifts in the premium segment and a decline in Qualcomm's share at an unnamed large customer. NEWS: On May 8, Reuters reported that EU antitrust regulators asked Qualcomm's competitors how the company's licensing and business practices affect them, and on July 16, the European Commission confirmed two formal antitrust investigations of the company. On May 25, Qualcomm and Daimler (DDAIF) announced a strategic collaboration to develop connected car technology. Coming on the heels of Avago's (AVGO) May 28 agreement to acquire Broadcom (BRCM), Bloomberg quoted a source later that day as saying Qualcomm, Intel (INTC), Altera (ALTR), Analog Devices (ADI), Maxim Integrated (MXIM), Texas Instruments (TXN), and Microchip Technology (MCHP) are all considering their own M&A opportunities. Note that on June 1, Intel announced an agreement to acquire Altera. On June 23, Semiconductor Manufacturing International (SMI), Qualcomm, Huawei, and Imec announced the formation of a joint venture to focus on a type of 14 nanometer technology. More recently, the Wall Street Journal reported on July 20 that Qualcomm is "expected" to begin a comprehensive strategic review which may include the possibility of a breakup following pressure from "activist" shareholder Jana Partners, according to sources, adding that the move could be announced concurrent with Wednesday's earnings release. STREET RESEARCH: Following last quarter's earnings report, Exane BNP Paribas downgraded Qualcomm to Neutral from Outperform, while both Canaccord and Brean Capital lowered price targets for the stock after "disappointing" guidance. Meanwhile, Citi said it expects the company's chip business to recover in 2016 despite this "very bad year." On May 28, CLSA said it sees continued pressure on Qualcomm chipsets, potentially spurring the company to consider making an acquisition, and on June 2, Craig-Hallum noted that Skyworks (SWKS) would be a great fit for Qualcomm. On June 24, Summit Research called Applied Micro Circuits (AMCC) an "affordable" target for Qualcomm, with AMD (AMD) and Cavium (CAVM) also looking like potential takeover candidates. On June 29, Drexel Hamilton downgraded Qualcomm to Sell from Hold, citing expected price cuts. Lastly, following media reports on July 20 that Qualcomm could be weighing a breakup, Bernstein said that such a "dis-synergistic" split would likely destroy value rather than create it. PRICE ACTION: Shares of Qualcomm are down more than 1% to $64.37 in afternoon trading ahead of Wednesday's earnings report.
12:38 EDTDISCADiscovery to acquire controlling stake in Eurosport from TF1
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12:35 EDTADIAnalog chip makers fall after Linear cites weak end market demand
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