New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 19, 2014
08:17 EDTSNY, RGLSRegulus Therapeutics nominates RG-102 as Orphan Drug candidate
Regulus Therapeutics (RGLS) nominated its second microRNA candidate for clinical development, RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport Syndrome, a life-threatening, genetic kidney disease with no approved therapy. Regulus is responsible for advancing RG-012 to proof-of-concept. At that stage of development, Regulus' strategic alliance partner, Sanofi (SNY), has an exclusive option exercisable after proof-of-concept to assume all costs, responsibilities and obligations for further development and commercialization of RG-012. If Sanofi chooses to exercise its option on RG-012, Sanofi will reimburse Regulus for a significant portion of its preclinical and clinical development costs and will pay Regulus an option exercise fee. Regulus is eligible to receive development and commercialization milestone payments and will have an option to co-promote in the United States or receive royalty payments in the mid 10% to 20% range.
News For RGLS;SNY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 30, 2015
06:55 EDTSNYSanofi having hard time finding new CEO, Reuters reports
Subscribe for More Information
January 28, 2015
14:40 EDTRGLSRegulus set to report more potentially stock moving data soon, TheStreet says
Subscribe for More Information
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 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use