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Sanofi SA (SASY.PA)

SASY.PA on Paris Stock Exchange

77.88EUR
19 Jun 2019
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Latest Key Developments (Source: Significant Developments)

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

Enable Injections Enters Into Strategic Partnership With Sanofi
Monday, 3 Jun 2019 

June 3 (Reuters) - Enable Injections Inc::ENABLE INJECTIONS ENTERS INTO STRATEGIC PARTNERSHIP WITH SANOFI.ENABLE INJECTIONS, DEVELOPER OF ADVANCED WEARABLE INFUSION DEVICES FOR COMBINATION PRODUCTS - ENTERS INTO MULTI-PRODUCT DEVELOPMENT AGREEMENT WITH SANOFI .  Full Article

Cegedim, Sanofi data cooperation for healthcare in Europe
Tuesday, 21 May 2019 

May 21 (Reuters) - Cegedim SA ::CEGEDIM AND SANOFI ARE ENGAGED IN AN INNOVATIVE COLLABORATION ON REAL WORLD DATA FOR HEALTHCARE IMPROVEMENT IN EUROPE.  Full Article

Sanofi and U.S. peer Alnylam conclude research and option phase of 2014 rare disease alliance
Monday, 8 Apr 2019 

April 8 (Reuters) - Sanofi SA ::* Sanofi and Alnylam have agreed to conclude the research and option phase of the companies' 2014 RNAi therapeutics alliance in rare genetic diseases. .* As part of this agreement, Alnylam will advance an additional investigational asset in an undisclosed rare genetic disease through the end of IND-enabling studies..* Sanofi will be responsible for any potential further development or commercialization of such asset. If this product is approved, Alnylam will be eligible to receive tiered double-digit royalties on its global net sales..* In addition, Alnylam and Sanofi have agreed to amend certain terms of the companies' equity agreement, with Sanofi obtaining a release of its lock-up of Alnylam stock holdings, subject to certain trading restrictions, amongst other provisions.  Full Article

Sanofi: FDA Issues CRL For Zynquista (Sotagliflozin) Informing That Application Cannot Be Approved In Its Present Form
Friday, 22 Mar 2019 

March 22 (Reuters) - SANOFI SA ::REG-SANOFI: FDA ISSUES COMPLETE RESPONSE LETTER FOR ZYNQUISTA(TM) (SOTAGLIFLOZIN).FDA ISSUED A COMPLETE RESPONSE LETTER (CRL) REGARDING NEW DRUG APPLICATION FOR INVESTIGATIONAL ZYNQUISTA((TM)) (SOTAGLIFLOZIN).CRL IS A COMMUNICATION FROM THE FDA THAT INFORMS COMPANIES THAT AN APPLICATION CANNOT BE APPROVED IN ITS PRESENT FORM.SANOFI AND LEXICON WILL WORK CLOSELY WITH FDA TO DETERMINE APPROPRIATE NEXT STEPS.  Full Article

FDA Approves Dupixent For Treatment Of Patients Aged 12 Years & Older With Moderate-To-Severe Atopic Dermatitis
Monday, 11 Mar 2019 

March 11 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS DUPIXENT APPROVED FOR TREATMENT OF PATIENTS AGED 12 YEARS AND OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS.  Full Article

Regeneron's Supplemental Submission For Dupixent Wins FDA Approval
Monday, 11 Mar 2019 

March 11 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON PHARMACEUTICALS INC'S SUPPLEMENTAL SUBMISSION FOR DUPIXENT WINS FDA APPROVAL - FDA WEBSITE.  Full Article

Sanofi/Regeneron: FDA priority review of Dupixent for some adults with nasal polyps issues
Friday, 8 Mar 2019 

March 8 (Reuters) - Sanofi SA /Regeneron ::* The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent(®) (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).* Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids.* The target action date for the FDA decision is June 26, 2019..* Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages.  Full Article

EMA Says CHMP Recommends Granting A Conditional Marketing Authorisation For Waylivra
Friday, 1 Mar 2019 

March 1 (Reuters) - EMA - :EMA - CHMP RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR ONDEXXYA.EMA - CHMP RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR WAYLIVRA.EMA - ZYNQUISTA INTENDED AS AN ADJUNCT TO INSULIN FOR CERTAIN PATIENTS WITH TYPE 1 DIABETES, RECEIVED A POSITIVE OPINION FROM CHMP.EMA - CHMP ADOPTED A POSITIVE OPINION, RECOMMENDING GRANTING OF A CONDITIONAL MARKETING AUTHORISATION FOR LORVIQUA.EMA - CHMP RECOMMENDED FOR APPROVAL GENERIC MEDICINE PAZENIR FOR TREATMENT OF METASTATIC BREAST CANCER AND NON-SMALL CELL LUNG CANCER.EMA - APPLICANT FOR DOXOLIPAD HAS REQUESTED A RE-EXAMINATION OF COMMITTEE'S NEGATIVE OPINION FOR THIS MEDICINE ADOPTED AT JANUARY 2019 MEETING.EMA - CHMP RECOMMENDED EXTENSION OF INDICATION OF DUPIXENT AS ADD-ON MAINTENANCE TREATMENT FOR PATIENTS 12 YRS & OLDER WITH FORMS OF SEVERE ASTHMA.EMA - CHMP WILL NOW RE-EXAMINE OPINION FOR DOXOLIPAD AND ISSUE A FINAL RECOMMENDATION.EMA - APPLICATION FOR AN INITIAL MARKETING AUTHORISATION FOR EPJEVY (PACRITINIB CITRATE) WAS WITHDRAWN.EMA - OTHER EXTENSIONS OF INDICATION RECOMMENDED BY COMMITTEE WERE FOR LYNPARZA, RIARIFY, TRYDONIS AND VIREAD.  Full Article

Sanofi SA Says European Commission To Make Decision On Marketing Authorization Application For Sotagliflozin In EU In Coming Months
Friday, 1 Mar 2019 

March 1 (Reuters) - Sanofi SA ::SANOFI : CHMP RECOMMENDS ZYNQUISTATM (SOTAGLIFLOZIN) FOR THE TREATMENT OF ADULTS WITH TYPE 1 DIABETES.SANOFI - EUROPEAN COMMISSION IS EXPECTED TO MAKE A FINAL DECISION ON MARKETING AUTHORIZATION APPLICATION FOR SOTAGLIFLOZIN IN EU IN COMING MONTHS.  Full Article

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Sanofi plans 466 job cuts as part of R&D reshuffle

PARIS Sanofi on Wednesday said a reorganization of its research and development operation in Germany and France would result in 466 job cuts in the two countries.