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News Breaks
August 14, 2014
09:11 EDTKSS, VIPS, PRGO, SUPN, ENPH, ARUN, NDLS, RHHBY, SNY, ITMN, DDD, SSYS, VJET, XONE, PLUG, KBIOOn 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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October 22, 2014
07:33 EDTDDD3D Systems reports preliminary Q3 EPS 16c-19c, consensus 21c
Reports Q3 revenue $164M-$169M, consensus $186M. CEO Avi Reichental stated, "We are disappointed that we failed to fully capitalize on the robust demand for our direct metal and consumer products during the quarter. While we worked very hard to deliver these products sooner, achieving manufacturing scale, quality and user experience targets took significantly longer than we had anticipated. Now that we have closed these availability gaps, we expect our revenue growth rate to increase"
October 21, 2014
16:18 EDTDDD3D Systems initiated with an Outperform at Oppenheimer
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16:18 EDTXONEExOne initiated with an Outperform at Oppenheimer
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16:17 EDTSSYSStratasys initiated with a Perform at Oppenheimer
08:32 EDTENPHEnphase Energy enters into energy storage business with AC Battery
Enphase Energy announced its Enphase AC Battery, which is fully integrated with the just-introduced Enphase Energy Management System. The modular battery provides system owners with the ability to store solar energy for nighttime or future use, optimizing solar power consumption and giving owners energy independence. The Enphase Energy Management System, including the Enphase AC Battery, will be available through authorized distribution channels in 2H15.
07:15 EDTRHHBYFDA to hold workshop on breast cancer drug development
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07:06 EDTSNYFierce Biotech to hold a breakfast meeting
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06:44 EDTPRGO, SNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
12:37 EDTRHHBYOn The Fly: Midday Wrap
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10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:22 EDTENPHSolar Energy Trade Shows to hold a conference
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07:19 EDTRHHBY, SNYIBC Life Sciences to hold a conference
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07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBY, SNYAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
October 17, 2014
11:58 EDTENPHEnphase Energy to host analyst day
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09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
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