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December 19, 2012
16:12 EDTFOLD, GSKAmicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed.
News For FOLD;GSK From The Last 14 Days
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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.
10:18 EDTFOLDOptions with decreasing implied volatility
Options with decreasing implied volatility: NKTR FOLD RUSL RSX ORCL GES CTRP SLXP WSM SPXS
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.
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.
16:26 EDTFOLDOn The Fly: Closing Wrap
Stocks on Wall Street opened lower but turned mixed early in the day and remained that way for most of the session. The Dow and S&P spent most of the day deep in negative territory, while the Nasdaq managed to stay just above the flat line. Investors had a chance to digest yesterday’s comments from the Fed and may have re-considered whether it latest policy stance was as dovish as originally believed. ECONOMIC EVENTS: In the U.S., initial jobless claims rose 1K to 291K in the week ended March 14, which nearly matched the consensus 293K forecast. The current account deficit widened to $113.5B in Q4 from a revised deficit of $98.9B in Q3. The leading indicators for February rose 0.2% to 121.4, which was in-line with expectations. The Philadelphia Fed business outlook survey ticked down to a 5.0 one-year low from 5.2 in February, missing expectations for it to have risen a 7.0 reading. COMPANY NEWS: Apple (AAPL) joined the Dow Jones Industrial Average after the close last night, replacing AT&T (T). Shares of Apple finished their first day in the blue chip index down 97c, or 0.76%, at $127.50, while AT&T fell 39c, or 1.16%, to $33.20... Coffee giant Starbucks (SBUX) rose $1.92, or 2%, to close at $97.76 after hitting a new all-time high of $99.20 earlier. The move follows the company's investor day meeting yesterday, where it unveiled plans for two pilots of delivery services, reported a partnership to expand the distribution of its ready-to-drink products in China, and announced that its board has declared the sixth two-for-one split of the company’s stock since its IPO in 1992. Goldman Sachs and Wells Fargo were both unphased by the record highs and predicted the rally is not over for Starbucks in upbeat notes on the stock today. MAJOR MOVERS: Among the notable gainers was Amicus Therapeutics (FOLD), which rose $3.11, or 33.26%, to $12.46 after reporting positive results in meetings with the EMA and FDA. Also higher was Wynn Resorts (WYNN), which gained $7.19, or 5.85%, to $130.11 after research firm Brean Capital last night initiated coverage of the stock and several casino peers with Buy ratings. Among the noteworthy losers was Transocean (RIG), which fell $1.09, or 7.15%, to $14.16 after saying that it intends to scrap four rigs and noting that with those it has announced plans to scrap a total of 16 floaters. Also lower after its earnings report was diversified apparel company Vince Holding (VNCE), which fell $3.50, or 16.36%, to $17.89. INDEXES: The Dow fell 117.16, or 0.65%, to 17,959.03, the Nasdaq gained 9.55, or 0.19%, to 4,992.38, and the S&P 500 declined 10.23, or 0.49%, to 2,089.27.
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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10:42 EDTFOLDOptions with decreasing implied volatility
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10:23 EDTFOLDHigh option volume stocks
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09:37 EDTFOLDActive equity options trading on open
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09:20 EDTFOLDOn The Fly: Pre-market Movers
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08:20 EDTFOLDAmicus to host conference call
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07:59 EDTFOLDAmicus NDA submission removes key overhang, says JPMorgan
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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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06:07 EDTFOLDAmicus reports positive results in meetings with EMA and FDA
Amicus has met with regulatory authorities in Europe and the U.S. to discuss the approval pathways for the oral small molecule pharmacological chaperone migalastat HCl as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations. The company held a meeting with the assigned European Rapporteurs to discuss the upcoming marketing authorization application for migalastat monotherapy. The Rapporteurs agreed that Amicus may submit its MAA for migalastat monotherapy under the Full Approval pathway in the EU and indicated support for Amicus to request Accelerated Assessment. Amicus is accelerating the timing of the MAA submission for full approval for migalastat monotherapy from the middle of 2015 to Q2. Amicus held a Type C meeting with the FDA and plans to submit an NDA for Accelerated Approval, for which the FDA is open to considering several potential surrogate endpoints evaluated in the clinical studies of migalastat. Amicus plans to schedule a pre-NDA meeting and to submit an NDA under Subpart H in 2H15
March 17, 2015
10:26 EDTFOLDOptions with increasing implied volatility
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07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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March 16, 2015
07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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