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Sanofi SA (SASY.PA)

SASY.PA on Paris Stock Exchange

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3 Dec 2020
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Latest Key Developments (Source: Significant Developments)

Kiadis Pharma and Sanofi Confirm Good Progress On Preparations For Offer
Monday, 30 Nov 2020 

Nov 30 (Reuters) - KIADIS PHARMA NV ::REG-UPDATE ON THE INTENDED OFFER BY SANOFI FOR KIADIS.SANOFI AND KIADIS CONFIRM THAT THEY ARE MAKING GOOD PROGRESS ON PREPARATIONS FOR OFFER.SANOFI AND KIADIS ANTICIPATE THAT OFFER WILL CLOSE IN FIRST HALF OF 2021.SANOFI AND KIADIS CONFIRM THAT PROCESS TO OBTAIN REQUIRED COMPETITION CLEARANCE FOR OFFER IS PROCEEDING.  Full Article

Sanofi: EC Approves MenQuadfi®, Latest Innovation In Meningococcal Vaccination For Individuals 12 Months Of Age And Older
Monday, 23 Nov 2020 

Nov 23 (Reuters) - Sanofi SA ::REG-EUROPEAN COMMISSION APPROVES MENQUADFI®, THE LATEST INNOVATION IN MENINGOCOCCAL (MENACWY) VACCINATION FOR INDIVIDUALS 12 MONTHS OF AGE AND OLDER.EFFICACY AND SAFETY PROFILES FOR MENQUADFI CONFIRMED IN ROBUST CLINICAL PROGRAM.IN ORDER TO BETTER ADDRESS GLOBAL NEED FOR MENINGOCOCCAL DISEASE PREVENTION OVER LIFE COURSE, PHASE 3 STUDIES ARE ONGOING TO INVESTIGATE VACCINE IN INFANTS FROM 6 WEEKS OF AGE .FOLLOWING EC APPROVAL, MENQUADFI IS EXPECTED TO BE AVAILABLE IN SEVERAL EUROPEAN COUNTRIES FROM 2021 TO HELP PROTECT INDIVIDUALS 12 MONTHS OF AGE AND OLDER.  Full Article

Sanofi: European Commission Approves Supemtek®
Wednesday, 18 Nov 2020 

Nov 18 (Reuters) - SANOFI SA ::REG-EUROPEAN COMMISSION APPROVES SUPEMTEK® (QUADRIVALENT RECOMBINANT INFLUENZA VACCINE) FOR THE PREVENTION OF INFLUENZA IN ADULTS AGED 18 YEARS AND OLDER.FIRST AND ONLY RECOMBINANT INFLUENZA VACCINE APPROVED IN EUROPEAN UNION.PHASE 3 EFFICACY TRIAL DEMONSTRATED IMPROVED PROTECTION AGAINST INFLUENZA COMPARED TO STANDARD-DOSE INFLUENZA VACCINE, AND REDUCED RISK OF INFLUENZA BY AN ADDITIONAL 30% IN ADULTS AGED 50 YEARS AND OLDER(1,2).CONTAINS THREE TIMES MORE ANTIGEN THAN STANDARD-DOSE VACCINES.FIRST EUROPEAN LAUNCHES ARE EXPECTED FOR 2022/2023 INFLUENZA SEASON.POSSIBILITY OF ACCELERATING AVAILABILITY OF DOSES AS EARLY AS 2021/2022 SEASON IN CERTAIN COUNTRIES.  Full Article

Sanofi: Fda Granted Rilzabrutinib Fast Track Designation
Wednesday, 18 Nov 2020 

Nov 18 (Reuters) - Sanofi SA ::RILZABRUTINIB GRANTED FDA FAST TRACK DESIGNATION FOR TREATMENT OF IMMUNE THROMBOCYTOPENIA.PHASE 3 TRIAL INITIATED TO EVALUATE RILZABRUTINIB, POTENTIAL FIRST BTK INHIBITOR FOR TREATMENT OF IMMUNE THROMBOCYTOPENIA.RILZABRUTINIB PREVIOUSLY GRANTED FDA ORPHAN DRUG DESIGNATION.  Full Article

Sanofi Announces FDA Granted Priority Review For Avalglucosidase Alfa
Wednesday, 18 Nov 2020 

Nov 18 (Reuters) - SANOFI SA ::FDA GRANTS PRIORITY REVIEW FOR AVALGLUCOSIDASE ALFA, A POTENTIAL NEW THERAPY FOR POMPE DISEASE.FDA DECISION DATE FOR AVALGLUCOSIDASE ALFA, AN INVESTIGATIONAL ENZYME REPLACEMENT THERAPY, IS SET FOR MAY 18, 2021.REGULATORY SUBMISSION BASED ON POSITIVE DATA FROM TWO TRIALS IN PATIENTS WITH LATE-ONSET AND INFANTILE-ONSET POMPE DISEASE, RESPECTIVELY.AVALGLUCOSIDASE ALFA RECEIVED FDA BREAKTHROUGH THERAPY AND FAST TRACK DESIGNATIONS FOR TREATMENT OF PEOPLE WITH POMPE DISEASE.POMPE DISEASE, A RARE DEGENERATIVE MUSCLE DISORDER, AFFECTS APPROXIMATELY 3,500 PEOPLE IN U.S..AVALGLUCOSIDASE ALFA IS CURRENTLY UNDER CLINICAL INVESTIGATION AND ITS SAFETY AND EFFICACY HAVE NOT BEEN EVALUATED BY ANY REGULATORY AUTHORITY WORLDWIDE.  Full Article

FDA Issues Complete Response Letter For Sutimlimab
Saturday, 14 Nov 2020 

Nov 13 (Reuters) - Sanofi SA ::FDA ISSUES COMPLETE RESPONSE LETTER FOR SUTIMLIMAB, AN INVESTIGATIONAL TREATMENT FOR HEMOLYSIS IN ADULTS WITH COLD AGGLUTININ DISEASE.SANOFI - COMPLETE RESPONSE LETTER REFERS TO DEFICIENCIES FROM A PRE-LICENSE INSPECTION OF A THIRD-PARTY MANUFACTURING FACILITY.SANOFI - THERE WERE NO CLINICAL OR SAFETY DEFICIENCIES NOTED IN CRL WITH RESPECT TO APPLICATION.SANOFI - SATISFACTORY RESOLUTION OF OBSERVATIONS BY THE THIRD-PARTY MANUFACTURER IS REQUIRED BEFORE THE BLA CAN BE APPROVED.SANOFI - REMAINS IN CLOSE CONTACT WITH THE FDA AND THE THIRD-PARTY MANUFACTURER TO REACH A RESOLUTION IN A TIMELY MANNER.  Full Article

Sanofi: EPO Rules In Sanofi And Regeneron's Favour On Praluent
Thursday, 29 Oct 2020 

Oct 29 (Reuters) - SANOFI SA ::EUROPEAN PATENT OFFICE RULES IN FAVOR OF SANOFI AND REGENERON CONCERNING PRALUENT® (ALIROCUMAB).RULING INVALIDATES AMGEN'S EUROPEAN PATENT CLAIMS DIRECTED TO PCSK9 ANTIBODIES RELEVANT TO PRALUENT(®) (ALIROCUMAB).PRALUENT(®) (ALIROCUMAB) CONTINUES TO BE AVAILABLE IN EUROPEAN COUNTRIES WHERE IT IS APPROVED FOR USE AND FOR SALE.  Full Article

Sanofi 2020 Business Earnings Per Share Guidance Revised Upwards
Thursday, 29 Oct 2020 

Oct 29 (Reuters) - Sanofi SA ::Q3 NET SALES AT EUR 9.48 BILLION, +5.7% AT CONSTANT FOREX (CER).Q3 NET INCOME EUR 1.95 BILLION, +10.5%.Q3 BUSINESS NET INCOME EUR 2.30 BILLION, +9.4% AT CONSTANT FOREX (CER).Q3 BUSINESS EPS EUR 1.83, +8.8% AT CONSTANT FOREX (CER).NOW EXPECTS 2020 BUSINESS EPS TO GROW BETWEEN 7% AND 8% AT CER.2020 BUSINESS EPS GUIDANCE REVISED UPWARDS.CURRENCY IMPACT ON 2020 BUSINESS EPS IS ESTIMATED TO BE BETWEEN -6% TO -7%.IN FIRST NINE MONTHS OF 2020, FREE CASH FLOW INCREASED BY 39.7% TO EUR 5,452 MILLION.OUR COVID-19 VACCINES DEVELOPMENT EFFORTS CONTINUE ON A FAST TRACK ALONG WITH ENSURING GLOBAL ACCESS WITH PRE-ORDERS SIGNED WITH MAJOR COUNTRIES, REGIONS, AND NON-PROFIT ORGANIZATIONS - CEO.NET DEBT DECREASED FROM EUR 15,107 MILLION AT DEC 31, 2019 TO EUR 9,644 MILLION AT SEPT 30, 2020 (AMOUNT NET OF EUR 13,014 MILLION CASH AND CASH EQUIVALENTS).  Full Article

Sanofi: to evaluate the safety and efficacy of novel investigational candidate THOR-707 and KEYTRUDA® (pembrolizumab)
Thursday, 29 Oct 2020 

Oct 29 (Reuters) - Sanofi SA ::REG-SANOFI TO EVALUATE THE SAFETY AND EFFICACY OF NOVEL INVESTIGATIONAL CANDIDATE THOR-707 AND KEYTRUDA® (PEMBROLIZUMAB) IN PURSUIT OF ESTABLISHING A NEW TREATMENT OPTION IN ONCOLOGY.Sanofi has entered into an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada) to conduct a Phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of THOR-707, a highly differentiated non-alpha IL-2 candidate with a best-in-class profile, combined with or in sequenced administration with MSD’s KEYTRUDA(®) (pembrolizumab) in patients with various cancers..Under the agreement, Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA..  Full Article

Sanofi And Parkinson's Foundation Announce New Research Collaboration
Wednesday, 21 Oct 2020 

Oct 21 (Reuters) - Sanofi SA ::SANOFI AND THE PARKINSON'S FOUNDATION COLLABORATE TO ADVANCE THE AVAILABILITY OF FREE GENETIC TESTING AND COUNSELING FOR PEOPLE WITH PARKINSON'S DISEASE.SANOFI WILL PROVIDE $1 MILLION IN RESEARCH FUNDING TO SUPPORT PD GENERATION: MAPPING FUTURE OF PARKINSON'S DISEASE INITIATIVE.  Full Article

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Sanofi to publish COVID-19 vaccine price in development with GSK after Phase I/II trial results

PARIS French drug maker Sanofi will announce the price of the potential COVID-19 vaccine it is developing with Britain's GlaxoSmithKline after it has released Phase I/II results of the trials, vaccines chief Thomas Triomphe said on Thursday.