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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Sanofi announes some positive Phase 3 trials for Dupixent® (dupilumab)
Wednesday, 16 May 2018 

May 16 (Reuters) - Sanofi ::* Dupixent® (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis.* U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018 .* A pivotal Phase 3 trial evaluating Dupixent (®)(dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints.* In the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures.* Dupixent is the first and only biologic to show positive results in this patient population, adds Sanofi.  Full Article

Sanofi And Ablynx Announce Commencement Of Squeeze-Out Tender Period
Monday, 14 May 2018 

May 14 (Reuters) - Ablynx NV ::SANOFI AND ABLYNX ANNOUNCE THE SUCCESSFUL RESULTS OF THE INITIAL TENDER OFFER PERIOD FOR ABLYNX AND COMMENCEMENT OF SQUEEZE-OUT TENDER PERIOD.ABLYNX NV - SANOFI CONFIRMED THAT MINIMUM TENDER CONDITION AND OTHER CONDITIONS TO OFFERS HAVE BEEN SATISFIE.ABLYNX NV - SANOFI HAS DECIDED TO PROCEED WITH A SQUEEZE-OUT OF THOSE SECURITIES NOT TENDERED TO OFFERS.  Full Article

Sanofi: FDA To Conduct Priority Review Of Cemiplimab As Potential Treatment For Advanced Cutaneous Squamous Cell Carcinoma
Monday, 30 Apr 2018 

April 30 (Reuters) - SANOFI SA ::REG-SANOFI: FDA TO CONDUCT PRIORITY REVIEW OF CEMIPLIMAB AS A POTENTIAL TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.  Full Article

Regeneron Says FDA To Conduct Priority Review Of Cemiplimab As A Potential Treatment For Advanced Cutaneous Squamous Cell Carcinoma
Monday, 30 Apr 2018 

April 30 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO CONDUCT PRIORITY REVIEW OF CEMIPLIMAB AS A POTENTIAL TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.SAYS TARGET ACTION DATE FOR FDA DECISION IS OCTOBER 28, 2018..  Full Article

FDA Accepts For Review Sanofi's Supplemental Biologics License Application
Wednesday, 25 Apr 2018 

April 25 (Reuters) - SANOFI SA ::FDA ACCEPTS FOR REVIEW SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR 0.5 ML DOSE OF FLUZONE® QUADRIVALENT (INFLUENZA VACCINE) IN CHILDREN 6-35 MONTHS OF AGE.DETAILED RESULTS FROM PHASE IV, RANDOMIZED, OBSERVER-BLINDED, CONTROLLED, MULTICENTER STUDY TO BE PRESENTED LATER THIS YEAR.PER THE PRESCRIPTION DRUG USER FEE ACT, THE TARGET ACTION DATE IS JANUARY 28, 2019.IF APPROVED, PHYSICIANS WILL BE ABLE TO RESERVE VACCINE FOR YOUNG CHILDREN FOR 2019-2020 FLU SEASON.  Full Article

Sanofi: EMA to review sotagliflozin as potential treatment for type 1 diabetes
Thursday, 29 Mar 2018 

March 29 (Reuters) - Sanofi ::* The European Medicines Agency (EMA) has accepted for review Sanofi's regulatory submission for sotagliflozin.* If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus.* Developed in partnership with Lexicon Pharmaceuticals, Inc., sotagliflozin is an investigational dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys process blood sugar (glucose).  Full Article

Bioverativ Says Regarding Termination Of Merger Deal With Sanofi Under Certain Circumstances Co Will Be Required To Pay Fee Of $326 Mln
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Bioverativ Inc ::BIOVERATIV SAYS REGARDING TERMINATION OF MERGER DEAL WITH SANOFI UNDER CERTAIN CIRCUMSTANCES CO WILL BE REQUIRED TO PAY FEE OF $326 MILLION - SEC FILING.  Full Article

Sanofi CFO sees commercial, cost and tax synergies following Bioverativ deal
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Sanofi Chief financial officer Jerome Contamine says ::sees commercial, cost and tax synergies related to the acquisition of U.S firm Bioverativ by France's Sanofi .  Full Article

Regeneron Announces Approval Of Dupixent (Dupilumab) In Japan For Treatment Of Atopic Dermatitis
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON ANNOUNCES APPROVAL OF DUPIXENT® (DUPILUMAB) IN JAPAN FOR THE TREATMENT OF ATOPIC DERMATITIS.REGENERON PHARMACEUTICALS - DUPIXENT IS BEING JOINTLY DEVELOPED BY CO, SANOFI UNDER A COLLABORATION AGREEMENT, & WILL BE COMMERCIALIZED IN JAPAN BY SANOFI.  Full Article

Sanofi nears deal to buy Hemophilia drugmaker Bioverativ for over $11.5 bln - WSJ
Monday, 22 Jan 2018 

Jan 21 (Reuters) - :SANOFI NEARS DEAL TO BUY HEMOPHILIA DRUGMAKER BIOVERATIV FOR MORE THAN $11.5 BILLION - WSJ, CITING SOURCES‍​.  Full Article

Study confirms higher risk of dengue in kids who got Sanofi vaccine

CHICAGO An analysis of data on Sanofi's dengue vaccine, which has been given to more than 800,000 school children in the Philippines, confirms it increases the risk of hospitalization and severe dengue in those who had never previously been infected with the mosquito-borne virus.