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November 12, 2012
16:21 EDTGSK, UNH, PCP, JEF, CLVS, SRPT, TRV, TIE, JCP, GILD, NYX, LUKOn The Fly: Closing Wrap
Stocks on Wall Street finished virtually unchanged as the holiday held trading volumes down. With bond markets and banks being closed for Veterans Day the averages stayed within a narrow range on either side of the flat line... ECONOMIC EVENTS: In the U.S. no economic data was released. In Asia, China’s exports rose 11.6% in October, topping forecasts. However, Japan's gross domestic product fell an annualized 3.5% in the three months through September and economists predict the nation’s economy will shrink again in the next quarter, meaning it will have moved into recession... COMPANY NEWS: Leucadia National (LUK) agreed to acquire the remaining 71.4% of Jefferies (JEF) it doesn't own for $17.66 per share in an all stock transaction and shares of Jefferies rose $2.00, or 14.02%, to $16.27. Also, after Friday's closing bell, Precision Castparts (PCP) announced a deal to buy Titanium Metals (TIE) for $16.50 per share, or $2.9B. Shares of Titanium Metals closed up $4.93, or 42.61%, to $16.50 and shares of Precision Castparts also advanced $8.36, or 4.88%, to $179.69... The NYSE (NYX) said that it is continuing to investigate issues that affected trading in 216 symbols. Affected symbols included Dow members Travelers (TRV) and United Health Care (UNH)... MAJOR MOVERS: Among the notable gainers was Gilead (GILD), up $8.91, or 13.71%, to $73.92 after the company reported that it did not detect hepatitis C virus, or HCV, in the RNA of 25 HCV patients four weeks after they were treated with the company's investigational drug. Also higher were shares of Sarepta Therapeutics (SRPT), up $4.38, or 19.25%, to $27.13 after a JMP Securities analyst said a Duchenne muscular dystrophy treatment developed by GlaxoSmithKline (GSK) that will compete with Sarepta's drug is unlikely be approved until 2014 or 2015. Among stocks trading lower was J.C. Penney (JCP), down $2.67, or 12.94%, to $17.97 as the stock continued its downtrend after last week's earnings miss and was downgraded to Underperform from Neutral at Credit Suisse. Also lower were shares of Clovis Oncology (CLVS), down $8.99, or 41.83%, to $12.50 after the company reported negative results from a cancer drug trial and said it would suspend all development of the drug pending further evaluation of the data... INDICES: The Dow gained 1.31, or 0.01%, to 12,816.70; the Nasdaq fell 0.61, or 0.02%, to 2,904.26; and the S&P 500 added 0.15, or 0.01%, to 1,380.00.
News For JEF;LUK;TIE;PCP;NYX;TRV;UNH;GILD;SRPT;GSK;JCP;CLVS From The Last 14 Days
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March 23, 2015
07:36 EDTGSKPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
07:19 EDTJEFCapital Link to hold a forum
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06:08 EDTGILDGilead implied volatility of 23 at lower end of index mean range
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March 22, 2015
17:01 EDTPCPWestern Digital, PACCAR, two others look discounted, Barron's says
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15:17 EDTGSKGSK looks to conclude negotiations with U.K. on vaccine cost, Bloomberg says
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15:05 EDTGILDGilead warns after hepatitis C patient taking heart drug dies, Bloomberg says
Gilead said in an e-mailed drug warning to health-care providers on Friday that nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest, says Bloomberg. Reference Link
March 20, 2015
16:00 EDTGILDOptions Update; March 20, 2015
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15:02 EDTGILDAcelRx names Howard Rosen as interim CEO
AcelRx Pharmaceuticals (ACRX) announced the appointment of Howard Rosen as interim CEO of AcelRx, effective April 1. Rosen is a technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences (GILD) and ALZA Corporation. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra and several private biopharmaceutical companies.
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.
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.
09:01 EDTJCPJ.C. Penney says general counsel Janet Dhillon to leave company
J.C. Penney said in a filing that effective March 20, Janet Dhillon, Executive Vice President, General Counsel and Secretary, is leaving J. C. Penney Company.
08:18 EDTUNHLeerink healthcare services analyst holds an analyst/industry conference call
Healthcare Services Analyst Gupte discusses Sustainable Growth Rate (SGR) and the proposed pay-fors and implications For Healthcare Services on an Analyst/Industry conference call to be held on March 20 at 11 am.
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.
16:01 EDTGILDOptions Update; March 19, 2015
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15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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09:08 EDTGILDNew Gilead HIV drug likely to be approved in mid-2015, says Argus
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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
13:30 EDTJCPJ.C. Penney trades lower after news of executive departures
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06:37 EDTLUKFXCM price target lowered to 50c from 75c at Citigroup
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