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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Lexicon Pharma Gives Preliminary Update For Zynquista
Saturday, 27 Jul 2019 

July 27 (Reuters) - Lexicon Pharmaceuticals Inc ::LEXICON PHARMACEUTICALS PROVIDES PRELIMINARY UPDATE FOR ZYNQUISTA™ (SOTAGLIFLOZIN) TYPE 2 DIABETES PHASE 3 PROGRAM.SANOFI HAS DELIVERED TO LEXICON A NOTICE PURPORTING TO TERMINATE ALLIANCE.NOTIFIED SANOFI THAT IT CONSIDERS NOTICE INVALID.RECEIVED PRELIMINARY TOPLINE RESULTS FROM SANOFI FOR THREE PHASE 3 TRIALS OF ZYNQUISTA.CONSIDERS SANOFI TO BE IN BREACH OF CONTRACT.HAS NOT YET RECEIVED UNDERLYING DATA, EXPECTS TO CONDUCT OWN REVIEW AND VALIDATION AND STATISTICAL ANALYSIS OF DATA WHEN THEY ARE RECEIVED.EXPECT CORE PHASE 3 PROGRAM WILL BE COMPLETED IN COMING MONTHS.IF VALID TERMINATION OF SANOFI ALLIANCE, CO WILL LOOK TO REGAINING FULL RIGHTS TO ZYNQUISTA IN TYPE 1 DIABETES IN U.S., REST OF THE WORLD.SOTA-CKD4 STUDY APPEARS TO HAVE NARROWLY MISSED STATISTICAL SIGNIFICANCE ON A1C.PREL TOPLINE RESULTS FROM SANOFI IN SOTA-MET SHOW ZYNQUISTA 400 MG DEMONSTRATED STATISTICALLY SIGNIFICANT REDUCTION IN BLOOD SUGAR CONTROL.  Full Article

Verastem Oncology Signs An Exclusive License Agreement With Sanofi
Friday, 26 Jul 2019 

July 25 (Reuters) - Verastem Inc ::VERASTEM ONCOLOGY SIGNS AN EXCLUSIVE LICENSE AGREEMENT WITH SANOFI FOR THE DEVELOPMENT AND COMMERCIALIZATION OF COPIKTRA® (DUVELISIB) IN RUSSIA AND CIS, TURKEY, THE MIDDLE EAST AND AFRICA.VERASTEM INC - ONCOLOGY SHALL RECEIVE AN UPFRONT PAYMENT OF $5 MILLION.VERASTEM INC - ELIGIBLE TO RECEIVE UP TO $42 MILLION USD IN DEVELOPMENT AND SALES MILESTONES AND DOUBLE-DIGIT PERCENTAGE ROYALTIES.VERASTEM INC - SANOFI OBTAINS RIGHTS TO DEVELOP AND COMMERCIALIZE COPIKTRA IN LICENSED TERRITORIES.  Full Article

Myokardia Announces HCM Program Updates Accelerates Timing For Mavacamten Topline Phase 3 Data
Thursday, 18 Jul 2019 

July 18 (Reuters) - MyoKardia Inc ::MYOKARDIA ANNOUNCES HCM PROGRAM UPDATES: ACCELERATES TIMING FOR MAVACAMTEN TOPLINE PHASE 3 DATA; RE-ACQUIRES U.S. ROYALTY RIGHTS TO HCM PROGRAMS FROM SANOFI.MYOKARDIA INC - ROYALTY PURCHASE CREATES ADDITIONAL ECONOMIC VALUE FOR MYOKARDIA'S EMERGING HCM TREATMENT PORTFOLIO.MYOKARDIA INC - EXPLORER-HCM PATIENT SCREENING CLOSES AHEAD OF SCHEDULE - INITIAL RESULTS NOW ANTICIPATED IN Q2 OF 2020.MYOKARDIA INC - RE-ACQUISITION OF U.S. ROYALTY RIGHTS TO MAVACAMTEN AND MYK-224 FROM SANOFI S.A..MYOKARDIA INC - MYOKARDIA NOW ANTICIPATES REPORTING TOPLINE DATA FROM EXPLORER-HCM TRIAL IN Q2 OF 20200.MYOKARDIA INC - AS CONSIDERATION FOR BUYBACK OF U.S. ROYALTY RIGHTS TO THESE PROGRAMS, MYOKARDIA IS PAYING SANOFI $50 MILLION UPFRONT.MYOKARDIA INC - PATIENT SCREENING HAS CLOSED FOR PHASE 3 EXPLORER-HCM REGISTRATIONAL CLINICAL STUDY.MYOKARDIA INC - ADDITIONAL $30 MILLION PAYABLE BY JUNE 30, 2020 FOR BUYBACK OF U.S. ROYALTY RIGHTS TO SOME PROGRAMS.MYOKARDIA INC - MYOKARDIA'S CASH GUIDANCE REMAINS UNCHANGED.MYOKARDIA INC - ANTICIPATES THAT CURRENT CASH, CASH EQUIVALENTS AND INVESTMENTS WILL BE SUFFICIENT TO FUND PLANNED OPERATIONS INTO SECOND HALF OF 2021.  Full Article

Amgen Comments On Pcsk9 Patent Litigation In Germany
Thursday, 11 Jul 2019 

July 11 (Reuters) - Amgen Inc ::AMGEN INC. - AMGEN COMMENTS ON PCSK9 PATENT LITIGATION IN GERMANY.AMGEN SAYS "PLANS TO ENFORCE THE COURT’S DECISION AGAINST PRALUENT IN GERMANY".AMGEN - DÜSSELDORF REGIONAL COURT RULED IN FAVOR OF AMGEN CONFIRMING THAT SANOFI-AVENTIS’ PRALUENT® (ALIROCUMAB) INFRINGES AN AMGEN PATENT.AMGEN INC - AT THIS TIME NOT SEEKING REMOVAL OF EXISTING PRALUENT SUPPLIES AVAILABLE AT HOSPITALS AND PHARMACIES.  Full Article

Catalent Extends Global Commercial Spray Drying Capabilities In Europe
Tuesday, 9 Jul 2019 

July 9 (Reuters) - Catalent Inc ::CATALENT EXTENDS GLOBAL COMMERCIAL SPRAY DRYING CAPABILITIES IN EUROPE.CATALENT INC - EXPANDED CAPACITY OF GLOBAL SPRAY DRYING OPERATIONS THROUGH AGREEMENT WITH SANOFI ACTIVE INGREDIENT SOLUTIONS.CATALENT - UNDER AGREEMENT SANOFI TO PROVIDE CO ACCESS TO SPRAY DRYING MANUFACTURING SERVICES FOR CO'S CUSTOMERS AT SANOFI'S HAVERHILL, U.K. FACILITY.  Full Article

BIOCORP Enters Exclusive Negotiations With Sanofi
Wednesday, 3 Jul 2019 

July 3 (Reuters) - BIOCORP PRODUCTION SA ::BIOCORP ENTERS EXCLUSIVE NEGOTIATIONS WITH SANOFI TO USE THEIR MALLYATM CONNECTED DEVICE WITH SANOFI’S INTEGRATED DIABETES CARE PLATFORM.BIOCORP ENTERS EXCLUSIVE NEGOTIATIONS WITH SANOFI TO USE THEIR MALLYATM CONNECTED DEVICE WITH SANOFI’S INTEGRATED DIABETES CARE PLATFORM.BIOCORP TO RECEIVE UPFRONT PAYMENT OF 4 MEUR.UNDER TERMS OF THESE EXCLUSIVE NEGOTIATIONS, BIOCORP WILL GET AN INITIAL PAYMENT OF EUR 4 MILLION FROM SANOFI TO SUPPORT RELATED DEVELOPMENT ACTIVITIES.  Full Article

Sanofi: Libtayo (Cemiplimab) Approved For Advanced Cutaneous Squamous Cell Carcinoma In EU
Monday, 1 Jul 2019 

July 1 (Reuters) - SANOFI SA ::REG-SANOFI : LIBTAYO® (CEMIPLIMAB) APPROVED FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA IN THE EUROPEAN UNION.  Full Article

Libtayo Approved For Advanced Cutaneous Squamous Cell Carcinoma In EU
Monday, 1 Jul 2019 

July 1 (Reuters) - Regeneron Pharmaceuticals Inc ::LIBTAYO® (CEMIPLIMAB) APPROVED FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA IN EUROPEAN UNION.REGENERON PHARMACEUTICALS INC - EUROPEAN COMMISSION HAS GRANTED CONDITIONAL MARKETING AUTHORIZATION FOR LIBTAYO.REGENERON - AS PART OF CONDITIONAL APPROVAL, CO, SANOFI WILL ADD NEW PATIENT GROUP TO EMPOWER-CSCC-1 TO FURTHER SUPPORT BENEFIT-RISK PROFILE OF LIBTAYO.  Full Article

Drugmaker Sanofi says U.S. FDA will review meningococcal vaccine candidate MenQuadfi
Thursday, 27 Jun 2019 

June 27 (Reuters) - Sanofi ::* The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi’s MenQuadfi(TM) Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis.* The target action date for the FDA decision is April 25, 2020..* If approved, MenQuadfi will be available in a fully liquid presentation..  Full Article

Sanofi Says Soliqua Phase 3 Results Significantly Lowered Blood Sugar Levels Compared To GLP-1 Receptor Agonist Treatments
Sunday, 9 Jun 2019 

June 9 (Reuters) - Sanofi SA ::SOLIQUA PHASE 3 RESULTS SIGNIFICANTLY LOWERED BLOOD SUGAR LEVELS COMPARED TO GLP-1 RECEPTOR AGONIST TREATMENTS.STUDY SHOWED A SAFETY PROFILE CONSISTENT WITH ESTABLISHED PROFILES OF TREATMENTS STUDIED.STUDY MOST COMMON CLASSES OF ADVERSE EVENT WERE GASTROINTESTINAL EVENTS (I.E., NAUSEA, DIARRHEA AND OR VOMITING) AND HYPOGLYCEMIA.  Full Article

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EU approves Sanofi, Regeneron's Dupixent for adolescent eczema cases

PARIS The Dupixent product developed by French healthcare company Sanofi and its U.S. partner Regeneron has won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents, the companies said.