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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Regulus Therapeutics Says Workforce Reduction Of About 60 Pct Is Being Implemented
Thursday, 5 Jul 2018 05:00pm EDT 

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 01:14am EDT 

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

Evotec To Integrate Sanofi's Infectious Diseases Unit
Monday, 18 Jun 2018 12:59am EDT 

June 18 (Reuters) - Evotec AG ::DGAP-NEWS: EVOTEC AND SANOFI SIGN DEFINITIVE AGREEMENT TO COMBAT INFECTIOUS DISEASES.100 EMPLOYEES WILL JOIN EVOTEC.SANOFI TO PROVIDE SIGNIFICANT SUPPORT TO EVOTEC INCLUDING A ONE-TIME, UPFRONT PAYMENT OF EUR 60 M.SANOFI WILL RETAIN CERTAIN OPTION RIGHTS ON DEVELOPMENT, MANUFACTURING AND COMMERCIALISATION OF ANTI-INFECTIVE PRODUCTS RESULTING FROM LICENSED ASSETS.TRANSACTION WILL RESULT IN INCREASED OPERATING INCOME AS WELL AS INCREASED RESEARCH AND DEVELOPMENT EXPENDITURE.TRANSACTION WILL BE SLIGHTLY ACCRETIVE TO EVOTEC'S EBITDA FOR NEXT FIVE YEARS.  Full Article

Translate Bio Announces Agreement With Sanofi Pasteur To Develop Vaccines For Infectious Diseases Using Novel mRNA Technology
Monday, 11 Jun 2018 07:00am EDT 

June 11 (Reuters) - Sanofi SA ::TRANSLATE BIO ANNOUNCES AGREEMENT WITH SANOFI PASTEUR TO DEVELOP VACCINES FOR INFECTIOUS DISEASES USING NOVEL MRNA TECHNOLOGY.TRANSLATE BIO SAYS SANOFI PASTEUR WILL MAKE AN UPFRONT PAYMENT OF $45 MILLION TO CO & IN TOTAL, CO IS ELIGIBLE TO RECEIVE UP TO $805 MILLION IN PAYMENTS.  Full Article

Bioverativ And Sangamo Announce FDA Acceptance Of Ind Application For Gene-Edited Cell Therapy BIVV003
Wednesday, 16 May 2018 07:30am EDT 

May 16 (Reuters) - Sangamo Therapeutics Inc ::BIOVERATIV AND SANGAMO ANNOUNCE FDA ACCEPTANCE OF IND APPLICATION FOR GENE-EDITED CELL THERAPY BIVV003 TO TREAT SICKLE CELL DISEASE.SANGAMO THERAPEUTICS - IND ENABLES BIOVERATIV TO INITIATE PHASE 1/2 CLINICAL TRIAL TO ASSESS SAFETY OF BIVV003 IN ADULTS WITH SICKLE CELL DISEASE.  Full Article

FDA Approves Toujeo® Max Solostar®
Tuesday, 27 Mar 2018 08:03am EDT 

March 27 (Reuters) - Sanofi Sa ::FDA APPROVES TOUJEO® MAX SOLOSTAR®.SANOFI - FDA APPROVED SANOFI'S TOUJEO (INSULIN GLARGINE 300 UNITS/ML) MAX SOLOSTAR.  Full Article

Alnylam Retains Global Rights To Lumasiran, Investigational RNAi Therapeutic For Treatment Of Primary Hyperoxaluria Type 1
Monday, 12 Mar 2018 07:00am EDT 

March 12 (Reuters) - Alnylam Pharmaceuticals Inc ::ALNYLAM RETAINS GLOBAL RIGHTS TO LUMASIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1).ALNYLAM PHARMACEUTICALS INC - ‍COMPANY PLANS TO ACCELERATE DEVELOPMENT WITH PHASE 3 START IN LATE 2018​.ALNYLAM PHARMACEUTICALS INC - ‍LUMASIRAN GRANTED BREAKTHROUGH THERAPY DESIGNATION BY UNITED STATES FOOD AND DRUG ADMINISTRATION​.ALNYLAM PHARMACEUTICALS INC - ‍SANOFI GENZYME HAS DECLINED ITS OPT-IN FOR DEVELOPMENT AND COMMERCIALIZATION OF LUMASIRAN​.  Full Article

FDA To Review Dupixent® (Dupilumab) As Potential Treatment For Moderate-To-Severe Asthma
Friday, 2 Mar 2018 01:00am EST 

March 2 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO REVIEW DUPIXENT® (DUPILUMAB) AS POTENTIAL TREATMENT FOR MODERATE-TO-SEVERE ASTHMA.‍PER PRESCRIPTION DRUG USER FEE ACT, TARGET ACTION DATE IS OCTOBER 20, 2018​.‍POTENTIAL USE OF DUPIXENT IN ASTHMA IS CURRENTLY UNDER CLINICAL DEVELOPMENT​.SAFETY AND EFFICACY FOR ‍DUPIXENT IN ASTHMA HAVE NOT BEEN FULLY EVALUATED BY ANY REGULATORY AUTHORITY​.  Full Article

Reg-Sanofi Announces Receipt Of Antitrust Clearances In Connection With The Acquisition Of Ablynx
Wednesday, 28 Feb 2018 12:21pm EST 

March 1 (Reuters) - Sanofi ::* Sanofi has received clearance from the Federal Cartel Office of Germany in accordance with the Act Against Restraints of Competition, applicable to Sanofi's proposed acquisition of Ablynx NV .  Full Article

Ablynx Announces Option Exercise By Sanofi To License Two Additional Target Combinations​
Friday, 16 Feb 2018 01:00am EST 

Feb 16 (Reuters) - ABLYNX NV ::ABLYNX ANNOUNCES OPTION EXERCISE BY SANOFI FOR TWO ADDITIONAL MULTI-SPECIFIC NANOBODY PRODUCT CANDIDATES.SANOFI HAS EXERCISED ITS OPTION TO LICENSE TWO ADDITIONAL TARGET COMBINATIONS​.‍OPTION AS PART OF RESEARCH COLLABORATION SIGNED IN JULY 2017​.‍SANOFI GAINS EXCLUSIVE GLOBAL RIGHTS TO TWO ADDITIONAL MULTI-SPECIFIC NANOBODIES AGAINST SELECTED TARGETS​.‍IN RETURN SANOFI WILL PAY ABLYNX EXERCISE FEES TOTALLING EUR 13 MILLION PLUS ADDITIONAL RESEARCH FUNDING​.‍ABLYNX HAS ALREADY RECEIVED AN UPFRONT PAYMENT TOTALLING EUR 23 MILLION.‍RECEIVED AN UPFRONT PAYMENT IS TOGETHER WITH RESEARCH FUNDING UNDER THIS COLLABORATION​.‍SANOFI WILL BE RESPONSIBLE FOR DEVELOPMENT, MANUFACTURING AND COMMERCIALISATION OF ANY PRODUCTS RESULTING FROM THIS AGREEMENT​.‍ABLYNX WILL BE ELIGIBLE TO RECEIVE DEVELOPMENT, REGULATORY AND COMMERCIAL MILESTONE PAYMENTS OF UP TO EUR 2.4 BILLION PLUS TIERED ROYALTIES​.  Full Article

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Sanofi halts production at Pyrenees plant after pollution complaint

PARIS Drugmaker Sanofi has stopped production at a plant in the French Pyrenees after an environment body filed a complaint against what it said was massive air pollution.