New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 12, 2013
04:55 EDTPLX, PLX, PLX, PLX, SHPG, SHPG, SHPG, SHPG, PFE, PFE, PFE, PFE, GEVA, GEVA, GEVA, GEVA, GSK, GSK, GSK, GSK, GENZ, GENZ, GENZ, GENZ, BMRN, BMRN, BMRN, BMRN, FOLD, FOLD, FOLD, FOLD, ALIOF, ALIOF, ALIOF, ALIOFLysosomal Disease Network / Nat'l Institues of Health to co-host a symposium
9th Annual WORLD Symposium is being held in Orlando on February 12-15.
News For PLX;SHPG;PFE;GEVA;GSK;GENZ;BMRN;FOLD;ALIOF From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | all recent news | >>
March 20, 2015
09:41 EDTSHPGBernstein global specialty pharma analyst holds analyst/industry conference call
Subscribe for More Information
08:12 EDTSHPGShire upgraded to Outperform from Market Perform at Bernstein
Bernstein upgraded Shire as the firm thinks that the stock's risk/reward ratio is positive following several new developments. Among these developments are the firm's belief that the company's orphan drug strategy looks increasingly strong, while the risks to the company's Vyvanse and mesalamines drugs look to have moderated and the company has several near-term, 2015 catalysts. Target $295.
07:55 EDTPFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
Subscribe for More Information
07:41 EDTPFEAmerican Academy of Dermatology to hold annual meeting
Subscribe for More Information
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
Subscribe for More Information
11:00 EDTPFEPfizer participates in a conference call with Bernstein
Subscribe for More Information
10:42 EDTFOLDOptions with decreasing implied volatility
Subscribe for More Information
10:23 EDTFOLDHigh option volume stocks
Subscribe for More Information
09:37 EDTFOLDActive equity options trading on open
Subscribe for More Information
09:20 EDTFOLDOn The Fly: Pre-market Movers
Subscribe for More Information
08:20 EDTFOLDAmicus to host conference call
Subscribe for More Information
07:59 EDTFOLDAmicus NDA submission removes key overhang, says JPMorgan
Subscribe for More Information
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
Subscribe for More Information
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 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
Subscribe for More Information
08:03 EDTSHPGTherapeuticsMD names Angus Russell, J. Martin Carroll as directors
TherapeuticsMD (TXMD) announced the appointment of two biopharmaceutical senior executives, Angus C. Russell and J. Martin Carroll, as independent members of its board of directors, and that Randall S. Stanicky has stepped down from the board of directors. Angus C. Russell served as CEO of Shire PLC (SHPG) from June 2008 until April 2013. J. Martin Carroll served as president and CEO of Boehringer Ingelheim Corp. U.S. from 2003 until 2011.
07:22 EDTSHPGShire looking for 'transformational' deal, Betaville blog says
Subscribe for More Information
1 | 2 | 3 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use