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August 14, 2014
09:11 EDTVIPS, ENPH, RHHBY, DDD, XONE, PRGO, ARUN, SNY, SSYS, PLUG, KBIO, SUPN, NDLS, ITMN, VJET, KSSOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
News For KSS;PLUG;XONE;VJET;SSYS;DDD;ITMN;SNY;RHHBY;NDLS;ARUN;ENPH;SUPN;PRGO;VIPS;KBIO From The Last 14 Days
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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
08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
January 22, 2015
08:20 EDTDDD3D Systems February volatility at low end of historic range
3D Systems February call option implied volatility is at 40, March is at 46; compared to its 26-week average of 47 according to Track Data. Low February option implied volatility suggests decreasing price movement into the expected release of Q4 results in late February.
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
16:32 EDTSUPNSupernus sues TWi for infringement of Oxtellar XR patents
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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.
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
07:53 EDTVJETvoxeljet sentiment can shift if company executes, says Brean Capital
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07:09 EDTDDD, SSYSPiper positive on Stratasys, cautious on 3D Systems after survey
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January 20, 2015
12:22 EDTVJETvoxeljet 2015 guidance 'encouraging,' says Piper Jaffray
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11:16 EDTPRGOPerrigo management to meet with B. Riley
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10:15 EDTDDD3D Systems call activity attributed to takeover speculation
3D Systems January weekly 29 and 30 calls are active on total call volume of 8,600 contracts (900 puts) on renewed takeover speculation. January weekly call option implied volatility is at 78, February is at 53, March is at 56; compared to its 26-week average of 47 according to Track Data. Active call volume suggests traders taking positions for price movement.
10:07 EDTDDDRumor: 3D Systems strength attributed to takeover speculation
Shares of 3D Systems are moving higher on speculation the company has hired an investment bank to review a potential sale of the company.
08:46 EDTVJETvoxeljet sees long-term revenue growth rate in the range of 50%
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08:45 EDTVJETvoxeljet sees FY15 revenue kEUR23,000-kEUR24,000
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07:26 EDTNDLSJefferies to hold a summit
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January 16, 2015
17:04 EDTSUPNSupernus sues Par Pharmaceuticals for patent infringement
Supernus Pharmaceuticals announced that it sued generic drug makers Par Pharmaceutical Companies, and Par Pharmaceutical, collectively known as Par, for infringement of four patents covering its antiepileptic drug Trokendi XR. Supernus' United States Patents Nos. 8,298,576, 8,298,580, 8,663,683 and 8,877,248 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR expires no earlier than 2027. The complaint, filed in the U.S. District Court for the District of New Jersey, alleges that Par infringed Supernus' Trokendi XR patents by submitting to the FDA an Abbreviated New Drug Application, ANDA, seeking to market a generic version of Trokendi XR prior to the expiration of Supernus' patents. Filing its complaint within 45 days of receiving Par's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Par's ANDA for 30 months.
16:36 EDTRHHBYMarket finishes week lower on continued oil, global growth worries
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11:02 EDTVIPSBofA/Merrill APAC equity derivatives analyst analyst/industry conference call
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06:21 EDTRHHBYRoche acquires Trophos for EUR120M plus contingent payments
Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime, TRO19622, which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology. Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120M, plus additional contingent payments of up to EUR 350M based on achievement of certain predetermined milestones.
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