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News Breaks
March 7, 2014
13:18 EDTSNY, REGN, AEGRRegeneron disclosed FDA contact about PCSK9 adverse events previously
Regeneron (REGN) stated in its 10-K filing on February 13 after the market close that the company its partner Sanofi (SNY) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Similar wording was included in a regulatory filing made today by Sanofi and may be a factor in the volatility seen in shares of Regeneron this afternoon. Shares of Regeneron are off their earlier lows but remain down about 7.8% near $312 per share. Shares of Aegerion (AEGR) spiked as Regeneron shares sold off, but are off their earlier highs. Aegerion remains up about 4.5% near $52.50 in afternoon trading.
News For SNY;REGN;AEGR From The Last 14 Days
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October 20, 2014
07:16 EDTREGNAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:10 EDTREGN, SNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNY, REGNRegeneron 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
09:06 EDTREGN, SNYAmgen 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.
07:07 EDTREGNRegeneron announces EYLEA results from NIH study
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October 16, 2014
08:36 EDTREGNRegeneron Genetics Center announces new collaborations and appointments
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08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
October 15, 2014
10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
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07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
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05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
16:13 EDTAEGRPoint72 Asset Management reports 5.2% passive stake in Aegerion
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11:23 EDTSNYBIND Therapeutics and The Conference Forum hold a conference
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09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
October 8, 2014
07:18 EDTSNYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
October 7, 2014
07:54 EDTSNYSanofi says alerted U.S. authorities about allegations of impropriety, WSJ says
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October 6, 2014
17:01 EDTREGNRegeneron reports EYLEA receives FDA approval for Macular Edema following RVO
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09:25 EDTSNYOn The Fly: Pre-market Movers
HIGHER: HP (HPQ), up 5% after confirming plans to separate into two companies... CareFusion (CFN), up 24% after Becton Dickinson (BDX) agreed to acquire the company for $58 per share in $12.2B deal. Becton Dickinson shares are up 7% following the news... Chimerix (CMRX), up 7% after announcing announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease... Conn's (CONN), up 6.5% after announcing that it is exploring strategic alternatives... TASER (TASR), up 5% after announces multiple orders of TASER Smart Weapons... Tableau (DATA), up 3.5% after upgraded at Morgan Stanley... Splunk (SPLK), up 3.9% after upgraded at Morgan Stanley... Unilife (UNIS), up 52% after signing a 15-year commercial supply agreement with Sanofi (SNY). LOWER: RadioShack (RSH), down 5% after confirming definitive agreements to restructure debt... Alcobra (ADHD), down 43% after announcing results from Phase III study of MDX in adult ADHD... Sunesis (SNSS), down 71% after announcing Phase 3 VALOR trial did not meet primary endpoint... H&R Block Bank (HRB), down 5% after deal with BofI (BOFI) not expected to get regulatory approval this year. Tekmira (TKMR), down 8% after downgraded at Leerink.
08:02 EDTSNYUnilife signs 15-year commercial supply agreement with Sanofi
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07:19 EDTSNY, REGNLeerink healthcare analysts hold an analyst/industry conference call
Healthcare Analysts discuss PCSK9 antibodies and evaluate the commercial potential and unmet need on an Analyst/Industry conference call. Relevant companies Amgen, Sanofi and Regeneron may be discussed on the Analyst/Industry conference call being held on October 6 at 11 am.
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