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Sanofi SA (SASY.PA)

SASY.PA on Paris Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Sanofi: FDA Issues CRL For Zynquista (Sotagliflozin) Informing That Application Cannot Be Approved In Its Present Form
Friday, 22 Mar 2019 02:15pm EDT 

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 03:34pm EDT 

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 03:28pm EDT 

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 01:02am EST 

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 08:16am EST 

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 08:01am EST 

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

Mylan Says U.S. Court Denied Sanofi's Motion Regarding Court Filing In Parties' Litigation On Sale, Marketing Of Epipen
Wednesday, 27 Feb 2019 06:42am EST 

Feb 27 (Reuters) - Mylan NV ::MYLAN SAYS ON JAN. 23, U.S. COURT DENIED SANOFI’S MOTION REGARDING SANOFI'S NOV. 1, 2018 COURT FILING IN PARTIES' LITIGATION ON SALE, MARKETING OF EPIPEN.MYLAN SAYS U.S. COURT DENIES SANOFI'S NOV. 1, 2018 MOTION FOR SUGGESTION OF REMAND OF CASE TO U.S. DISTRICT COURT FOR DISTRICT OF NEW JERSEY - SEC FILING.  Full Article

Regeneron And Sanofi Disagree With Verdict Upholding 3 Of 5 Amgen U.S. Patent Claims Relating To PCSK9 Antibodies
Monday, 25 Feb 2019 05:22pm EST 

Feb 25 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON AND SANOFI STRONGLY DISAGREE WITH VERDICT UPHOLDING THREE OF FIVE AMGEN U.S. PATENT CLAIMS RELATING TO PCSK9 ANTIBODIES.REGENERON PHARMACEUTICALS INC - CONTINUE TO BELIEVE IN DIFFERENTIATED CLINICAL PROFILE OF PRALUENT.REGENERON - CO, SANOFI TO FILE POST-TRIAL MOTIONS WITH DISTRICT COURT OVER NEXT FEW MONTHS, SEEKING TO OVERTURN JURY VERDICT & REQUESTING NEW TRIAL.REGENERON PHARMACEUTICALS INC - IF NECESSARY SANOFI, CO PLAN TO APPEAL TO U.S. COURT OF APPEALS FOR FEDERAL CIRCUIT.REGENERON PHARMACEUTICALS INC - VERDICT DOES NOT IMPACT U.S. PHYSICIANS' AND PATIENTS' ACCESS TO PRALUENT.  Full Article

Jury Upholds Amgen's Patents On Repatha (Evolocumab)
Monday, 25 Feb 2019 04:56pm EST 

Feb 25 (Reuters) - Amgen Inc ::JURY UPHOLDS AMGEN'S PATENTS ON REPATHA® (EVOLOCUMAB).AMGEN INC - JURY DELIVERED A VERDICT IN AMGEN'S FAVOR UPHOLDING VALIDITY OF TWO AMGEN PATENTS RELATED TO PCSK9 ANTIBODIES.AMGEN INC - JURY FOUND THAT AMGEN PATENTS MEET LEGAL REQUIREMENTS OF WRITTEN DESCRIPTION AND ENABLEMENT.AMGEN INC - AMGEN IS SEEKING TO ENFORCE PCSK9 ANTIBODY PATENTS PATENTS IN NATIONAL COURTS IN EUROPE AND JAPAN AGAINST SANOFI AND REGENERON.  Full Article

Sanofi And Regeneron Offer Praluent At New Reduced U.S. List Price
Monday, 11 Feb 2019 06:59am EST 

Feb 11 (Reuters) - Sanofi ::SANOFI AND REGENERON OFFER PRALUENT AT NEW REDUCED U.S. LIST PRICE.SANOFI - PRALUENT TO BE MADE AVAILABLE AT REDUCED U.S. LIST PRICE OF $5,850 ANNUALLY, DOWN 60 PERCENT FROM ORIGINAL PRICE, FOR BOTH 75 MG AND 150 MG DOSES.NEW LOWER-PRICED PRALUENT IS EXPECTED TO BE AVAILABLE FOR PHARMACIES TO ORDER IN EARLY MARCH.PRALUENT'S OUT-OF-POCKET COSTS FOR MEDICARE PATIENTS COULD BE LOWERED TO ABOUT $25 TO $150 PER MONTH, DEPENDING ON THEIR INSURANCE PLAN.  Full Article

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FDA rejects Sanofi-Lexicon add-on pill for type 1 diabetes

The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday.