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Sanofi SA (SASY.F)

SASY.F on Frankfurt Stock Exchange

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22 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Alnylam's genetic disease drug meets main goal in phase 3 study
Wednesday, 20 Sep 2017 06:59am EDT 

Sept 20 (Reuters) - Alnylam Pharmaceuticals Inc :Sanofi and Alnylam report positive topline results from APOLLO phase 3 study of patisiran in Hereditary ATTR (HATTR) amyloidosis patients with polyneuropathy.Alnylam Pharmaceuticals Inc - intends to file new drug application (NDA) in late 2017 and marketing authorisation application (MAA) in early 2018‍​.Alnylam Pharmaceuticals - ‍​investigational RNAI therapeutic patisiran meets primary and all secondary endpoints.Alnylam Pharmaceuticals Inc - "overall safety profile of patisiran was encouraging"‍​.Alnylam Pharmaceuticals- all five other secondary endpoints demonstrated statistically significant favorable differences in patisiran arm versus placebo ‍​.Alnylam Pharmaceuticals - in trial, at 18 months, mean change from baseline in MNIS+7 was significantly lower in patisiran group versus placebo‍​.  Full Article

Daily blood glucose measures in phase 3 clinical trials showed better stability with Sanofi's toujeo vs insulin glargine 100 units/ml
Wednesday, 13 Sep 2017 07:01am EDT 

Sept 13 (Reuters) - Sanofi SA :Daily blood glucose measures in phase 3 clinical trials demonstrated better stability with Sanofi's toujeo versus insulin glargine 100 units/ml.Sanofi - ‍improvements in blood glucose stability were statistically significant in edition 2 and senior, and for night-time measurements in edition 3​.  Full Article

Sanofi, Regeneron say Cemiplimab receives U.S. FDA breakthrough designation for advanced cutaneous squamous cell carcinoma
Friday, 8 Sep 2017 12:58am EDT 

Sept 8 (Reuters) - :Sanofi, Regeneron: Cemiplimab receives FDA breakthrough designation for advanced cutaneous squamous cell carcinoma.Sanofi - pending data results, co and Regeneron anticipate submitting a biologics license application for Cemiplimab with the FDA in Q1 2018.Sanofi - Cemiplimab is currently under clinical development, its safety and efficacy has not been fully evaluated by any regulatory authority.  Full Article

Sanofi says receives tentative FDA approval of Admelog
Friday, 1 Sep 2017 02:00pm EDT 

Sept 1 (Reuters) - Sanofi Sa : :Sanofi receives tentative FDA approval of Admelog® (insulin lispro injection) 100 units/ml.Sanofi - ‍With tentative approval, FDA concluded that Admelog met all necessary regulatory requirements for approval in U.S.​.  Full Article

Sanofi completes the acquisition of Protein Sciences
Monday, 28 Aug 2017 01:20am EDT 

Aug 28 (Reuters) - Sanofi ::* Completed the acquisition of Protein Sciences, a vaccines biotechnology company based in Meriden, Connecticut in the United States.* Sanofi said in July that it would buy Protein Sciences for an initial amount of $650 million nASM000CSF.  Full Article

Paulson & Co cuts share stake in Teva Pharmaceutical, Sanofi
Monday, 14 Aug 2017 05:10pm EDT 

Aug 14 (Reuters) - Paulson & Co:Paulson & Co Inc cuts share stake in Teva Pharmaceutical Industries Ltd by 38.7 percent to 6.7 million sponsored ADR - SEC filing.Paulson & Co Inc cuts share stake in Sanofi by 65.3 percent to 52,000 sponsored ADR.Paulson & Co Inc - Change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

Sanofi files suit in U.S. to defend patent rights on Lantus
Tuesday, 8 Aug 2017 03:32pm EDT 

Aug 8 (Reuters) - Sanofi SA ::Sanofi files suit in the U.S. to defend its patent rights on Lantus.Says ‍filed a patent infringement suit against Merck Sharp & Dohme Corp​.Says ‍in its suit co alleges infringement of two patents​.  Full Article

Sanofi files suit in U.S. to defend patent rights on Lantus
Tuesday, 8 Aug 2017 03:31pm EDT 

Aug 8 (Reuters) - SANOFI ::REG-SANOFI FILES SUIT IN THE U.S. TO DEFEND ITS PATENT RIGHTS ON LANTUS.‍ANNOUNCED THAT IT FILED A PATENT INFRINGEMENT SUIT AGAINST MERCK SHARP & DOHME CORP. ("MERCK") ON AUGUST 8, 2017 IN UNITED STATES DISTRICT COURT FOR DISTRICT OF NEW JERSEY.IN ITS SUIT SANOFI ALLEGES INFRINGEMENT OF TWO PATENTS.​.  Full Article

Regeneron Q2 non-gaap earnings per share $4.17
Thursday, 3 Aug 2017 06:30am EDT 

Aug 3 (Reuters) - Regeneron Pharmaceuticals Inc :Regeneron reports second quarter 2017 financial and operating results.Q2 non-gaap earnings per share $4.17.Q2 earnings per share view $3.17 -- Thomson Reuters I/B/E/S.Sees 2017 eylea u.s. Net product sales approximately 10% growth over 2016.Sees 2017 capital expenditures $250 million - $285 million.Regeneron pharmaceuticals inc - qtrly ‍total revenues $1,470 million versus $1,213​ million.Regeneron pharmaceuticals inc - ‍raised estimated full year 2017 eylea u.s. Net sales growth guidance to approximately 10% over 2016​.Regeneron pharmaceuticals inc says q2 2017 eylea(®) (aflibercept) injection u.s. Net sales increased 11% to $919 million versus q2 2016.Q2 revenue view $1.35 billion -- Thomson Reuters I/B/E/S.Q2 gaap earnings per share $3.34.Regeneron pharmaceuticals inc - in q2, global net sales of praluent were $46 million, compared to $24 million in the second quarter of 2016‍​.Regeneron pharmaceuticals inc - sees fy ‍sanofi reimbursement of regeneron commercialization-related expenses to be $370 million - $400 million​.  Full Article

Sanofi genzyme says PEI Pharmacare has added Lemtrada to pharmacare formulary
Tuesday, 1 Aug 2017 12:27pm EDT 

Aug 1 (Reuters) - Sanofi Genzyme :Sanofi Genzyme says PEI Pharmacare has added Lemtrada to pharmacare formulary.  Full Article

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Korea tensions keep European shares in check before Germany vote

LONDON/MILAN European shares steadied on Friday, as tensions over North Korea kept some investors on the sidelines ahead of a national election in Germany that conservative Chancellor Angela Merkel looks set to win.