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News Breaks
May 3, 2013
06:42 EDTSNY, REGNRegeneron acquires full rights to two novel development programs from Sanofi
Regeneron Pharmaceuticals (REGN) announced that it has expanded its ophthalmology portfolio by acquiring full exclusive rights to two families of novel antibodies invented at Regeneron and previously included in Regeneron's antibody collaboration with Sanofi (SNY). Regeneron acquired full rights to antibodies targeting the PDGF, or platelet derived growth factor, family of receptors and ligands in ophthalmology and all other indications and to antibodies targeting the ANG2 receptor and ligand in ophthalmology. Antibodies to PDGF and ANG2 are currently in preclinical development for use in ophthalmology. With respect to PDGF antibodies, Regeneron will pay Sanofi $10M upfront, up to $40M in development milestone payments, and royalties on sales. With respect to ANG2 antibodies in ophthalmology, Regeneron will pay Sanofi $10M upfront, a potential $5M development milestone payment, and royalties on sales.
News For REGN;SNY From The Last 14 Days
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January 26, 2015
05:14 EDTSNY, REGNRegeneron, 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
07:39 EDTREGNRegeneron announces EYLEA Injection recommended for approval in EU
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTREGN, SNYLeerink 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.
January 14, 2015
06:36 EDTREGNRegeneron price target raised to $474 from $390 at Citigroup
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January 13, 2015
13:50 EDTREGNRegeneron sees FY14 EYLEA U.S. sales about $1.735B
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12:40 EDTREGNAmgen off highs after Express Scripts CEO talks PCSK9 costs
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January 12, 2015
08:37 EDTSNYShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

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