New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis Data support frexalimab as a potential first-in-class, high-efficacy, non-lymphocyte depleting treatment for relapsing multiple sclerosis 96% of participants receiving high-dose intravenous frexalimab had no new Gd+ T1 lesions and an annualized relapse rate of 0.04 after 48 weeks Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS and non-relapsing secondary progressive...
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,529,599,938 € Registered office : 46, avenue de la Grande Armée - 75017 Paris - France Registered at the Paris Commercial and...
COMBINED GENERAL MEETING OF APRIL 30, 2024 AVAILABILITY OF PREPARATORY DOCUMENTS The Company’s shareholders are invited to attend the Combined General Meeting to be held on Thursday April 30, 2024 at 2:30 p.m. (CET) at the Palais des Congrès – Amphithéâtre Bleu – 2, place de la Porte Maillot – 75017 Paris. The notice of meeting ( avis de réunion ), including the agenda and the draft resolutions as well as the terms and conditions for participating and voting in the meeting, was...
Dupixent ® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation Priority Review granted based on positive results from two Phase 3 trials If approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade Regulatory submissions are also under review in China and Europe Paris and Tarrytown, N.Y. February 23, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review...
Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors Paris, February 22, 2024 . At its meeting on February 22, 2024, Sanofi’s Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting to be held on April 30, 2024, the renewal of the terms of office of Rachel Duan and Lise Kingo and the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent...
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,529,599,938 € Registered office : 46, avenue de la Grande Armée - 75017 Paris - France Registered at the Paris Commercial and...
Japan first in the world to approve Dupixent ® for chronic spontaneous urticaria (CSU) Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally Paris and Tarrytown, N.Y. February 16, 2024. The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent ® (dupilumab)...
Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS High-dose frexalimab significantly reduced disease activity, demonstrating 89% reduction in new brain lesions Phase 3 trials in relapsing MS and non-relapsing secondary progressive MS currently underway Paris, February 15, 2024. The New England Journal of Medicine published results from a positive Phase 2 clinical trial demonstrating frexalimab significantly slowed disease activity in people with...
Sanofi Delivers Solid Sales and Business EPS Growth at CER Amidst Successful Product Launches and Advancements in Immunology Pipeline Paris, February 1, 2024 Q4 2023 sales growth of 9.3% at CER and business EPS (1) increase of 8.2% at CER Specialty Care grew 13.7% driven by Dupixent and ALTUVIIIO launch performance, more than offsetting competition from generics of Aubagio in all key markets Vaccines sales increased strongly (up 21.1%) mainly as a result of the unprecedented uptake of Beyfortus,...
Brian Foard appointed Head of Specialty Care Global Business Unit, member of Sanofi Executive Committee Paris, January 9, 2024 . Brian Foard, a healthcare industry veteran and Sanofi leader in the U.S., has been named Head of the company’s Specialty Care Global Business Unit (GBU). With this appointment, which is effective immediately, Brian becomes a member of Sanofi’s Executive Committee. Brian has been interim Head of the GBU since September 2023 while also serving as Head of Specialty...
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,529,036,828 € Registered office : 46, avenue de la Grande Armée - 75017 Paris - France Registered at the Paris Commercial and...
Availability of the Q4 2023 Memorandum for modelling purposes Paris, France – December 15, 2023 . Sanofi announced today that its Q4 2023 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/q4-results-2023 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on...
Statement on FTC challenge to proposed license agreement with Maze Therapeutics Paris, December 11, 2023 . Sanofi is disappointed with the Federal Trade Commission’s announcement that it is seeking a preliminary injunction against a proposed licensing agreement between Sanofi and Maze Therapeutics. The agreement, announced on May 1, 2023, is for MZE001, a glycogen synthase 1 (GYS1) inhibitor program that has completed Phase 1 and is in development for Pompe Disease, a rare, inherited and often...
Sarclisa ® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa...
R&D Day Sanofi Pipeline Transformation to Accelerate Growth Driven by Record Number of Potential Blockbuster Launches, Paving the Way to Industry Leadership in Immunology Details strong pipeline including Sanofi’s record 12 blockbuster opportunities under clinical evaluation: 9 innovative medicines and vaccines with €2 to 5 billion peak sales potential, and 3 ‘pipeline-in-a-product’ assets with a potential of over €5 billion peak sales Strategic transformation through R&D features...
Dupixent ® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease NOTUS trial met its primary endpoint with overwhelming efficacy, showing Dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation (ie, blood eosinophils ≥300 cells per μL), confirming results from the...
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,529,036,828 € Registered office : 46, avenue de la Grande Armée - 75017 Paris - France Registered at the Paris Commercial and...
Sanofi Enters Next Chapter of Play to Win Strategy Increases investments in its pipeline to fully realize long-term growth potential, bolstered by successful launches and R&D progress. Launches strategic cost initiatives, with most of the savings to be reallocated to fund innovation and growth drivers. Announces intention to separate the Consumer Healthcare Business at the earliest in Q4 2024 via the creation of a publicly listed entity headquartered in France. Reiterates capital allocation...
Sanofi delivers first medicines from Global Health Unit’s Impact brand portfolio Paris, October 19, 2023. Sanofi has delivered the first medicines from its Global Health Unit’s not-for-profit Impact brand portfolio to the Republic of Djibouti. Enoxaparin Sodium Impact is an anticoagulant medicine indicated for the treatment of venous thromboembolism including deep vein thrombosis, a potentially lethal disease often underdiagnosed on the African continent. With this first shipment to...
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,529,036,828 € Registered office : 46, avenue de la Grande Armée - 75017 Paris - France Registered at the Paris Commercial and...
