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News Breaks
February 4, 2014
07:32 EDTGSK, JNJ, SNY, BMYMajor drug firms create pact for medicine development, WSJ reports
Ten major drug companies formed a pact for five years to cooperate on a government-backed effort with the National Institutes of Health to speed up the discovery of new medicines, reports the Wall Street Journal. Reference Link
News For BMY;JNJ;GSK;SNY From The Last 14 Days
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July 24, 2015
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.
14:08 EDTBMYBristol-Myers confirms FDA approval of hepatitis drug Daklinza
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13:49 EDTBMYFDA approves new treatment for chronic hepatitis C genotype 3
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11:02 EDTBMYBristol-Myers selects Jones Lang LaSalle for facility management
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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
18:21 EDTBMYOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
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07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
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06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
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July 22, 2015
15:26 EDTBMYNotable companies reporting before tomorrow's open
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10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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July 21, 2015
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
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.
09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
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