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News Breaks
May 14, 2014
09:18 EDTMM, RUBI, TTWO, SODA, P, BMY, GSK, CSIQ, PLUG, SNE, ENZY, ISIS, PTX, FOSL, CLDXOn The Fly: Pre-market Movers
HIGHER: Pernix Therapeutics (PTX), up 42% after acquiring TREXIMET tablets for migraine from GlaxoSmithKline (GSK)... Isis Pharmaceuticals (ISIS), up 9.6% after Phase 2 results for ISIS-GCGR for diabetes reported... Canadian Solar (CSIQ), up 1.7% after partnering with Ikea to build 3.6MW solar systems... Pandora (P), up 1.4% following upgrade at Raymond James... Rubicon Project (RUBI), up 22% after upgraded at Oppenheimer and RBC Capital following its Q1 earnings report... Celldex (CLDX), up 10.5% after announcing collaboration agreement with Bristol-Myers (BMY)... Millennial Media (MM), up 3.4% after CEO Barrett purchases 291K shares. LOWER: Sony (SNE), down 5.6% after reporting FY13 results, guiding to losses in FY14... DOWN AFTER EARNINGS: Fossil (FOSL), down 6.5%... Enzymotec (ENZY), down 8.6%... Plug Power (PLUG), down 6.6%... SodaStream (SODA), down 3.2%... Take-Two (TTWO), down 3.5%.
News For SNE;P;CLDX;PLUG;SODA;FOSL;CSIQ;TTWO;PTX;GSK;RUBI;ISIS;BMY;MM;ENZY From The Last 14 Days
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March 23, 2015
07:15 EDTCSIQCredit Suisse to hold a conference
18th Annual Asian Investment Conference is being held in Hong Kong on March 23-27.
07:04 EDTISISIsis Pharmaceuticals says ISIS-ANGPTL3Rx 'well tolerated' in Phase 1 study
Isis Pharmaceuticals announced positive results from a Phase 1 study with ISIS-ANGPTL3Rx. In this study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 of up to 93% with a mean reduction of up to 84% from baseline. In addition, statistically significant reductions from baseline in lipid parameters were observed, including up to 63% with a mean reduction of up to 49% in triglycerides and up to 46% with a mean reduction of up to 28% in total cholesterol. ANGPTL3 is a protein that acts as a key regulator of these blood lipids. These data were presented at the 83rd European Atherosclerosis Society in Glasgow, United Kingdom. The Phase 1 study of ISIS-ANGPTL3Rx was a blinded, placebo-controlled, dose-escalation study in healthy volunteers. The study was designed to assess the safety, tolerability and pharmacokinetics of ISIS-ANGPTL3Rx. ISIS-ANGPTL3Rx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg per week up to 400 mg per week for the multiple dose. In this study, ISIS-ANGPTL3Rx was generally well tolerated.
06:00 EDTSNESony to reduce TV, smartphone orders to Taiwan partners, DigiTimes reports
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March 22, 2015
15:17 EDTGSKGSK looks to conclude negotiations with U.K. on vaccine cost, Bloomberg says
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March 20, 2015
12:41 EDTGSKOn The Fly: Midday Wrap
Stocks began the day sharply higher and have continued to tack on gains throughout the morning. The market’s move put the Nasdaq back above 5,000 and the S&P above 2,100. The market is undergoing quadruple witching, which occurs 4 times per year and typically is accompanied by high volume and volatility. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. The Baker Hughes U.S. rig count, which has been closely watched in recent months amid the protracted slide in oil prices, is expected at 1:00 pm EDT. The count of U.S. rigs stood at 1125 at the end of last week. In Europe, reports indicate German Chancellor Angela Merkel said Greece has agreed to send a list of overhauled reforms to European officials within days. COMPANY NEWS: Shares of Nike (NKE) advanced 4% following its Q3 earnings beat. Credit Suisse raised Nike's price target to $106 following the report, saying Nike's underlying futures growth remains in double-digits and preliminary FY16 guidance suggests management has been effective in managing currency headwinds... The shares of Biogen (BIIB) rallied 8% after the company reported results for an early stage study of its Alzheimer's drug, BIIB-037. The company announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. MAJOR MOVERS: Among the notable gainers was Prothena (PRTA), which surged 30% after announcing results from a Phase 1 single ascending dose study of its potential treatment of Parkinson's disease. Also higher was Darden Restaurants (DRI), which gained 4% after the owner of the Olive Garden and Long Horn restaurant chains reported earnings that beat expectations. Among the noteworthy losers was China's Youku Tudou (YOKU), which dropped 9% and was downgraded to Sell at Deutsche Bank after the company reported mixed Q4 results. Also lower was Theravance (THRX), which fell 7% after the company and partner GlaxoSmithKline (GSK) announced that an FDA advisory committee voted that the efficacy data for their Breo Ellipta inhaler provides substantial evidence of a clinically meaningful benefit in adults, however it voted against approval for the proposed indication in 12-17 year olds. INDEXES: Near midday, the Dow was up 189.04, or 1.05%, to 18,148.07, the Nasdaq was up 40.24, or 0.81%, to 5,032.62, and the S&P 500 was up 19.54, or 0.94%, to 2,108.81.
11:45 EDTISISIsis Pharmaceuticals management to meet with Needham
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09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
07:55 EDTBMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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06:55 EDTCSIQU.S. delegates to work with China on environmental issues, China Daily says
The U.S. government is sending several high-level representatives to China in an effort to advance cooperation on energy, the environment and climate change, China Daily reported yesterday. The two countries signed a major climate change deal in November, the newspaper noted. Publicly traded companies in the solar energy space include Canadian Solar (CSIQ), First Solar (FSLR), JA Solar (JASO), SunPower (SPWR), Trina Solar (TSL) and Yingli Green Energy (YGE). Reference Link
06:36 EDTSNEWeb TV companies ask internet providers for special treatment, WSJ says
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06:06 EDTSNESony Mobile expected to reach revised smartphone shipment target, DigiTimes says
Sony Mobile said its Q4 smartphone shipments increased 20.2% sequentially to 11.9M units, reports DigiTimes. According to Taiwan-based hanset component suppliers, Sony Mobile is expected ship over 8M smartphones in the first calendar quarter of 2015, allowing the vendor to reach its revised target of 39.2M units for FY14. Reference Link
March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO® ELLIPTA®), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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March 18, 2015
12:09 EDTSNESony announces launch of PlayStation Vue in New York, Chicago, Philadelphia
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10:00 EDTPOn The Fly: Analyst Upgrade Summary
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09:23 EDTPOn The Fly: Pre-market Movers
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06:30 EDTCSIQChina raises 2015 solar energy target, Barron's says
China increased its 2015 solar energy installation target to 17.8 gigawatts from 15 gigawatts previously, according to Barron's.Additionally, Beijing abandoned its previous practice of setting targets for both large scale utility solar facilities and rooftop projects, which should help Chinese solar companies, Barron's quoted Deutsche Bank as saying. Chinese solar stocks rallied in New York yesterday. Companies in the sector include JinkoSolar (JKS) Trina Solar (TSL) Canadian Solar (CSIQ),, Yingli Green Energy (YGE), and JA Solar (JASO). Reference Link
06:28 EDTPPandora upgraded to Buy from Fair Value at CRT Capital
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