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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

FDA Grants Priority Review For Dupixent As Potential Treatment For Adolescents With Uncontrolled Moderate-To-Severe Atopic Dermatitis
Tuesday, 6 Nov 2018 

Nov 6 (Reuters) - Sanofi SA ::FDA GRANTS PRIORITY REVIEW FOR DUPIXENT® (DUPILUMAB) AS POTENTIAL TREATMENT FOR ADOLESCENTS WITH UNCONTROLLED MODERATE-TO-SEVERE ATOPIC DERMATITIS.SANOFI - TARGET ACTION DATE FOR FDA DECISION IS MARCH 11, 2019..  Full Article

Regulus Announces Successful Restructuring Of Sanofi Collaboration
Tuesday, 6 Nov 2018 

Nov 6 (Reuters) - Regulus Therapeutics Inc ::REGULUS ANNOUNCES SUCCESSFUL RESTRUCTURING OF SANOFI COLLABORATION.REGULUS THERAPEUTICS INC - REGULUS IS ELIGIBLE TO RECEIVE APPROXIMATELY $7 MILLION IN UPFRONT AND MATERIAL TRANSFER PAYMENTS..REGULUS THERAPEUTICS - UNDER TERMS OF AMENDMENT, CO IS ELIGIBLE TO RECEIVE ABOUT $7 MILLION IN UPFRONT AND MATERIAL TRANSFER PAYMENTS.REGULUS THERAPEUTICS INC - SANOFI WILL ASSUME DEVELOPMENT OF RG-012 FOR ALPORT SYNDROME.REGULUS THERAPEUTICS INC - REGULUS IS ALSO ELIGIBLE TO RECEIVE UP TO $40 MILLION IN DEVELOPMENT MILESTONE PAYMENTS.REGULUS THERAPEUTICS - SANOFI WILL REIMBURSE CO FOR CERTAIN OUT-OF-POCKET TRANSITION ACTIVITIES & ASSUME CO'S UPSTREAM LICENSE ROYALTY OBLIGATIONS.REGULUS - SANOFI TO ASSUME ALL FUTURE COSTS AND DEVELOPMENT ACTIVITIES ASSOCIATED WITH ADVANCEMENT OF RG-012, CURRENTLY IN PHASE 2 FOR ALPORT SYNDROME.  Full Article

FDA Grants Priority Review For Sanofi's Dengue Vaccine Candidate
Tuesday, 30 Oct 2018 

Oct 30 (Reuters) - Sanofi SA ::FDA GRANTS PRIORITY REVIEW FOR SANOFI'S DENGUE VACCINE CANDIDATE.SANOFI - FDA HAS ACCEPTED A BIOLOGICS LICENSE APPLICATION FOR SANOFI PASTEUR'S DENGUE VACCINE.SANOFI - FDA SET A PRESCRIPTION DRUG USER FEE ACT ACTION DATE OF MAY 1 FOR SANOFI PASTEUR'S DENGUE VACCINE.SANOFI - EUROPEAN COMMISSION IS EXPECTED TO GRANT MARKETING AUTHORIZATION FOR DENGVAXIA IN DEC 2018.  Full Article

FDA approves asthma indication for Dupixent (dupilumab)
Friday, 19 Oct 2018 

Oct 19 (Reuters) - Sanofi SA ::SANOFI - FDA APPROVES DUPIXENT AS MAINTENANCE THERAPY IN ASTHMA PATIENTS 12 YRS, OLDER WITH EOSINOPHILIC PHENOTYPE/ORAL CORTICOSTEROID-DEPENDENT ASTHMA.  Full Article

Sanofi to launch new Primary Care and China/Emerging Market business units
Thursday, 13 Sep 2018 

Sept 13 (Reuters) - Sanofi SA ::* To refocus two global business units (GBU).* Will create new Primary Care GBU that combines the product portfolios of Sanofi's existing Diabetes and Cardiovascular (DCV) GBU with Established Products, which are currently part of the General Medicines & Emerging Markets (GEM) GBU.* Creating a second new global business unit called China & Emerging Markets to be led by Olivier Charmeil, currently head of the GEM GBU..* Dieter Weinand to lead new Primary Care business unit.* Stefan Oelrich, currently head of the DCV GBU, has decided to leave Sanofi and will join Bayer AG .* Sanofi expects to launch the new Primary Care and China & Emerging Markets global business units by the beginning of 2019.  Full Article

U.S. FDA to review supplemental Biologics License Application for Praluent®
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Sanofi SA ::* U.S. Food & Drug Administration (FDA) to review supplemental Biologics License Application for Praluent(®) (alirocumab) Injection as potential treatment to reduce major adverse cardiovascular events.* FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy.* Praluent is being developed by Regeneron and Sanofi under a global collaboration agreement.  Full Article

Regeneron Says U.S. FDA Accepted Supplemental Biologics License Application For Praluent(Alirocumab) Injection
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO REVIEW SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRALUENT® (ALIROCUMAB)INJECTION AS POTENTIAL TREATMENT TO REDUCE MAJOR ADVERSE CARDIOVASCULAR EVENTS.REGENERON PHARMACEUTICALS -CO, SANOFI ANNOUNCED THAT U.S. FDA ACCEPTED SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRALUENT(ALIROCUMAB) INJECTION.FDA SET A PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE OF APRIL 28, 2019.  Full Article

Dyadic International Announces Research Collaboration With Sanofi-Aventis
Friday, 7 Sep 2018 

Sept 7 (Reuters) - Dyadic International Inc ::DYADIC INTERNATIONAL ANNOUNCES RESEARCH COLLABORATION WITH SANOFI-AVENTIS.DYADIC INTERNATIONAL - ENTERED INTO FULLY FUNDED RESEARCH COLLABORATION TO EXPLORE POTENTIAL OF ITS C1 TECHNOLOGY WITH SANOFI-AVENTIS DEUTSCHLAND GMBH.DYADIC INTERNATIONAL INC - OTHER TERMS OF RESEARCH COLLABORATION ARE CONFIDENTIAL.  Full Article

Regulus Therapeutics Says Workforce Reduction Of About 60 Pct Is Being Implemented
Thursday, 5 Jul 2018 

July 5 (Reuters) - Regulus Therapeutics Inc ::REGULUS ANNOUNCES STRATEGIC UPDATE AND CORPORATE RESTRUCTURING.REGULUS ANNOUNCES STRATEGIC UPDATE AND CORPORATE RESTRUCTURING.EFFORTS AIMED AT EXTENDING CASH RUNWAY TO MID-2019.WORKFORCE REDUCTION OF APPROXIMATELY 60% IS BEING IMPLEMENTED.RECRUITMENT ACTIVITIES FOR RG-012 CLINICAL PROGRAM IN ALPORT SYNDROME HAVE BEEN PAUSED.ACTIONS ANTICIPATED TO YIELD OVER $20 MILLION OF ANNUALIZED SAVINGS, WHICH ARE INTENDED TO EXTEND CO'S CASH RUNWAY INTO MID-2019.DISCUSSIONS WITH SANOFI TO POTENTIALLY RESTRUCTURE PARTNERSHIP ARE ONGOING.RGLS4326 HAS BEEN GENERALLY SAFE AND WELL-TOLERATED IN PHASE 1 SINGLE ASCENDING DOSE (SAD) AND MAD STUDIES TO DATE.REGULUS THERAPEUTICS - VOLUNTARILY PAUSED PHASE 1 MULTIPLE ASCENDING DOSE STUDY FOR RGLS4326 DUE TO UNEXPECTED OBSERVATIONS IN 27-WEEK MOUSE CHRONIC TOXICITY STUDY.REGULUS- INITIATED INVESTIGATIVE STUDIES, PLANNING NEW 27-WEEK MOUSE CHRONIC TOXICITY STUDY WITH SOME CHANGES BELIEVED TO ADDRESS UNEXPECTED FINDINGS.REGULUS - IN NEAR-TERM, WILL CONCENTRATE EFFORTS ON INVESTIGATING UNEXPECTED MOUSE TOXICITY FINDINGS IN RGLS4326 PROGRAM, ADVANCING HBV PROGRAMS.  Full Article

Sanofi, Advent finalise talks for acquisition of Sanofi's Zentiva
Thursday, 28 Jun 2018 

June 28 (Reuters) - Sanofi SA statement::SANOFI AND ADVENT FINALIZE NEGOTIATIONS FOR THE ACQUISITION OF ZENTIVA BY ADVENT.SANOFI, ADVENT HAVE FINISHED NEGOTIATIONS FOR ACQUISITION OF ZENTIVA, SANOFI'S EUROPEAN GENERICS BUSINESS BY ADVENT.SHARE PURCHASE AGREEMENT WORTH EUR 1.9 BILLION (ENTERPRISE VALUE).The companies announced that they had entered into exclusive talks on April 17, 2018..The transfer of the Zentiva business to Advent is anticipated during the course of the fourth quarter of 2018.  Full Article

Express Scripts offers new formulary for lower list-price drugs

Nov 13 Express Scripts Holding Co on Tuesday announced a new drug reimbursement list with lower U.S. prices for brand-name medications, as a way to encourage drugmakers to move away from paying rebates after a prescription is filled.