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Stock Market & Financial Investment News

News Breaks
April 11, 2014
07:06 EDTAUXL, SNY, VVUSVIVUS announces avanafil clinical data presentation
VIVUS (VVUS) announced that a poster describing results of a clinical study examining onset of action of avanafil will be presented during the 29th Annual European Association of Urology Congress. STENDRA, or avanafil, is approved by the FDA in the U.S. for the treatment of erectile dysfunction. VIVUS has granted Auxilium Pharmaceuticals (AUXL) exclusive marketing rights to STENDRA in the U.S. and Canada. Auxilium is in the early stages of commercializing STENDRA in the U.S. SPEDRA is the trade name for avanafil in the European Union and is approved by the European Medicines Agency for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to Sanofi (SNY) to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.
News For VVUS;SNY;AUXL From The Last 14 Days
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January 30, 2015
06:55 EDTSNYSanofi having hard time finding new CEO, Reuters reports
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January 29, 2015
16:35 EDTAUXLEndo sees Auxilium transaction immediately accretive
Endo International plc (ENDP)announced it has completed the acquisition of Auxilium Pharmaceuticals (AUXL) in a transaction valued at $2.6B when announced on October 9, 2014. The closing of the transaction follows the approval of the acquisition by Auxilium's shareholders on January 27 and the receipt of all required regulatory approvals. Rajiv De Silva, president and CEO of Endo, stated, This strategic transaction enhances the organic growth of our branded pharmaceuticals business by adding a broad range of high quality products to our already robust portfolio and expanding our development pipeline. We are excited to deliver on the promise of this combination by leveraging our resources to enhance the performance of XIAFLEX and optimize TESTOPEL and STENDRA. We continue to expect the transaction to be immediately accretive for shareholders and meaningfully accretive each year moving forward. We believe that Endo is now even better positioned to drive growth across our product portfolio and to capitalize on additional future strategic M&A opportunities to create value for shareholders, customers and employees." Auxilium common stock will cease to be traded on the NASDAQ Global Market following the close of trading on January 29.
07:16 EDTVVUSVIVUS reports EC approval of SPEDRA
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January 27, 2015
09:35 EDTAUXLAuxilium shareholders approve merger with Endo
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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
10:02 EDTVVUSOn the Fly: Analyst Initiation Summary
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09:21 EDTVVUSOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Infinera (INFN), up 13.2%... E-Trade (ETFC), up 5.6%... Starbucks (SBUX), up 5%... ResMed (RMD), up 3.2%. ALSO HIGHER: IVUS (VVUS), up 6.2% after being initiated with an Outperform at RBC Capital... Vitae Pharmaceuticals (VTAE), up 12.3% after 3M share Secondary priced at $11.90... lululemon (LULU), up 3.5% after being upgraded to Overweight from Neutral at JPMorgan. DOWN AFTER EARNINGS: Kimberly Clark (KMB), down 4.6%... Bank of New York Mellon (BK), down 2.1%... Altera (ALTR), down 4.4%... Kansas City Southern (KSU), down 3.3%... McDonald's (MCD), down fractionally. ALSO LOWER: LeapFrog (LF), down 32.8% after reporting preliminary third quarter results and withdrawing fiscal 2015 guidance... Molycorp (MCP), down 10.7% after being downgraded to Neutral from Buy at DA Davidson... Dreamworks (DWA), down 12% after announcing that it will cut 500 jobs, reduce films released per year, and seeing a $55M charge for 'The Penguins of Madagascar' and 'Mr. Peabody and Sherman'... Otonomy (OTIC), down 1.8% after secondary increased to 2.55M shares, priced at $29.25.
January 22, 2015
18:28 EDTVVUSOn The Fly: After Hours Movers
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16:15 EDTVVUSVIVUS initiated with an Outperform at RBC Capital
14:03 EDTAUXLAuxilium to host special shareholder meeting
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.

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