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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

FDA To Review Supplemental Biologics License Application
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO REVIEW SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRALUENT® (ALIROCUMAB) INJECTION AS POTENTIAL TREATMENT TO REDUCE MAJOR ADVERSE CARDIOVASCULAR EVENTS.REGENERON PHARMACEUTICALS INC - FDA SET A PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE OF APRIL 28, 2019.  Full Article

Sanofi Launches Drug For Treatment Of Multiple Sclerosis In India
Monday, 6 Aug 2018 

Aug 6 (Reuters) - Sanofi SA ::SANOFI LAUNCHES ORAL TABLET AUBAGIO FOR TREATMENT OF MULTIPLE SCLEROSIS IN INDIA.  Full Article

Sanofi And Revolution Medicines Partner To Develop Potential Targeted Treatments For Multiple Cancers
Wednesday, 18 Jul 2018 

July 18 (Reuters) - Sanofi SA ::SANOFI AND REVOLUTION MEDICINES LAUNCH GLOBAL PARTNERSHIP TO DEVELOP POTENTIAL FIRST-IN-CLASS TARGETED TREATMENTS FOR MULTIPLE CANCERS.SANOFI -COS EXPECT TO BEGIN FIRST-IN-HUMAN CLINICAL TRIALS WITH RMC-4630 IN SECOND HALF OF 2018.SANOFI - COMPANIES WILL JOINTLY DEVELOP SHP2 INHIBITORS, WHICH ARE DESIGNED TO REDUCE CELL GROWTH SIGNALING THAT IS OVERACTIVE IN CANCER.SANOFI - TO GET EXCLUSIVE WORLDWIDE LICENSE FOR COMMERCIALIZATION OF APPROVED PRODUCTS TARGETING SHP2, SUBJECT TO U.S. CO-PROMOTE OPTION FOR REVOLUTION.SANOFI - IN COLLABORATION, COMPANIES WILL JOINTLY DEVELOP SHP2 INHIBITORS.  Full Article

Sanofi Invests EUR 66 Mln In Chengdu, Sichuan Province, China
Monday, 2 Jul 2018 

July 2 (Reuters) - Sanofi SA ::SANOFI TO FURTHER ACCELERATE ITS SCIENTIFIC PRESENCE WITH THE OPENING OF A GLOBAL RESEARCH AND DEVELOPMENT OPERATIONS HUB IN CHENGDU, CHINA.SANOFI - INVESTS EUR 66 MILLION IN CHENGDU, SICHUAN PROVINCE, CHINA.  Full Article

European regulator CHMP approves Sanofi's Cablivi
Friday, 29 Jun 2018 

June 29 (Reuters) - Sanofi SA ::* The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Cablivi (caplacizumab) in Europe for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder..* Cablivi was developed by Ablynx, a Sanofi company.* The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for Cablivi in the European Union is expected in the coming months. .  Full Article

Sanofi completes previously announced acquisition of Ablynx
Tuesday, 19 Jun 2018 

June 19 (Reuters) - Sanofi ::* Sanofi completes its acquisition of Ablynx following the expiration of the Squeeze-out Procedure .* Sanofi announced 3.9 bln euros takeover of Ablynx back in January nL8N1PO145.  Full Article

Sanofi announes some positive Phase 3 trials for Dupixent® (dupilumab)
Wednesday, 16 May 2018 

May 16 (Reuters) - Sanofi ::* Dupixent® (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis.* U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018 .* A pivotal Phase 3 trial evaluating Dupixent (®)(dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints.* In the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures.* Dupixent is the first and only biologic to show positive results in this patient population, adds Sanofi.  Full Article

Sanofi And Ablynx Announce Commencement Of Squeeze-Out Tender Period
Monday, 14 May 2018 

May 14 (Reuters) - Ablynx NV ::SANOFI AND ABLYNX ANNOUNCE THE SUCCESSFUL RESULTS OF THE INITIAL TENDER OFFER PERIOD FOR ABLYNX AND COMMENCEMENT OF SQUEEZE-OUT TENDER PERIOD.ABLYNX NV - SANOFI CONFIRMED THAT MINIMUM TENDER CONDITION AND OTHER CONDITIONS TO OFFERS HAVE BEEN SATISFIE.ABLYNX NV - SANOFI HAS DECIDED TO PROCEED WITH A SQUEEZE-OUT OF THOSE SECURITIES NOT TENDERED TO OFFERS.  Full Article

Sanofi: FDA To Conduct Priority Review Of Cemiplimab As Potential Treatment For Advanced Cutaneous Squamous Cell Carcinoma
Monday, 30 Apr 2018 

April 30 (Reuters) - SANOFI SA ::REG-SANOFI: FDA TO CONDUCT PRIORITY REVIEW OF CEMIPLIMAB AS A POTENTIAL TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.  Full Article

Regeneron Says FDA To Conduct Priority Review Of Cemiplimab As A Potential Treatment For Advanced Cutaneous Squamous Cell Carcinoma
Monday, 30 Apr 2018 

April 30 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO CONDUCT PRIORITY REVIEW OF CEMIPLIMAB AS A POTENTIAL TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.SAYS TARGET ACTION DATE FOR FDA DECISION IS OCTOBER 28, 2018..  Full Article

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Sanofi pledges to keep up its restructuring efforts

(This version of the Sept. 14th story has been refiled to add dropped words in fifth paragraph)