New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 19, 2014
08:17 EDTRGLS, SNYRegulus 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
Check below for free stories on RGLS;SNY the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
July 30, 2014
16:31 EDTSNYRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
12:33 EDTSNYRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
Subscribe for More Information
08:08 EDTSNYSanofi and Regeneron report positive Phase 2 results of alirocumab
Subscribe for More Information
July 28, 2014
09:02 EDTSNYSanofi, InnerWorkings sign global marketing partnership
Subscribe for More Information
July 21, 2014
08:18 EDTRGLSRegulus Therapeutics granted orphan drug designation for RG-012 by FDA
Regulus Therapeutics announced that the FDA has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. In the near term, Regulus expects to initiate a natural history of disease study to gather further information about the progression of Alport syndrome and to inform future clinical development plans of RG-012, a key program under Regulus' 'Clinical Map Initiative'.
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
Subscribe for More Information
July 18, 2014
15:04 EDTRGLSWedbush reiterates Outperform rating on Regulus after orphan designation
Subscribe for More Information
11:05 EDTRGLSRegulus Therapeutics treatment of Alport syndrome designated as orphan drug
Subscribe for More Information

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