Press Releases 2021

Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics

Press Release: Gilles SCHNEPP takes over as Chairman of the Appointments, Governance and CSR Committee of Sanofi

Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation

Data from two Phase 3 studies demonstrating fitusiran significantly reduced bleeds in people with hemophilia A or B, with or without inhibitors, were featured at ASH’s plenary and late-breaking sessions

Positive Phase 3 Dupixent® (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session

Sarclisa® (isatuximab) trial is first Phase 3 study to meet primary endpoint of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma

New England Journal of Medicine publishes positive Phase 3 Dupixent® (dupilumab) results in children with moderate-to-severe asthma

EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD

Vaccines Investor Event: Sanofi reiterates confidence in strong growth outlook and showcases pipeline of innovative vaccine candidates

Sanofi to acquire Origimm Biotechnology in first move to treat acne with vaccine-based immunotherapy

Sanofi invests $180 million equity in Owkin’s artificial intelligence and federated learning to advance oncology pipeline

Sanofi announces results of CHMP re-examination of the New Active Substance status for avalglucosidase alfa, a potential new standard of care for the treatment of Pompe disease

Sanofi completes acquisition of Kadmon

New data in blood cancers, hemophilia, and other hematological disorders to be presented at ASH 2021

Sanofi: Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)

Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease

Dupixent® (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease

FDA expands approval of Dupixent® (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma

New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 

Update from Sanofi regarding Kevzara® (sarilumab): Supply constraints anticipated until early 2022

Sanofi: Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations

New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis

Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate

Sanofi announces positive Phase 1/2 study interim results for its first mRNA-based vaccine candidate

New research presented at IDWeek 2021 reinforces Sanofi’s robust vaccines pipeline and commitment to advancing public health protection

Sanofi: Availability of the Q3 2021 Memorandum for modelling purposes

New Dupixent® (dupilumab) data in patients as young as 6 years old with moderate-to-severe atopic dermatitis to be presented at WCPD and EADV

ESMO late-breaking data show Libtayo® (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC

Sanofi completes acquisition of Translate Bio, accelerating the application of mRNA in new vaccines and therapeutics

Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus

Sanofi to acquire Kadmon to further strengthen growth of transplant business

Dupixent® (dupilumab) efficacy and quality of life data in asthma patients across multiple age groups to be presented at 2021 ERS international congress

Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

Phase 3 trial of Libtayo® (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer

Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development

Online availability of Sanofi’s half-year financial report for 2021

Sanofi appoints new leaders to Executive Committee and announces future Chair of EUROAPI

Sales growth accelerated - Full-year guidance raised

Dupixent® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients  

Sanofi provides update on avalglucosidase alfa EU submission for patients with Pompe Disease

Sanofi continues streamlining of established products with sale of dental care brands to Septodont

US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness

Conversion of Kiadis to a private limited liability company postponed until completion of statutory buy-out proceedings

Sanofi streamlines Consumer Healthcare portfolio in Latin America with divestiture of eight brands to Hypera Pharma

Sanofi announces Paris 2024 Premium partnership for the Olympic and Paralympic Games in Paris

MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers

Sanofi highlights scientific innovations in the field of rare blood disorders at ISTH 2021

Sanofi launches dedicated vaccines mRNA Center of Excellence

New Soliqua® data shows improved blood sugar control without weight gain versus premixed insulin

Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial

Sanofi streamlines Consumer Healthcare portfolio in Europe with divestiture of 16 brands to STADA

Dupixent® (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis

Sanofi: Availability of the Q2 2021 Memorandum for modelling purposes

Sanofi: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma

Sanofi: Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

European Commission approves Aubagio® (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis

New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia  

Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S.

Sanofi launches its new global employee share ownership plan

Sanofi partnering with leading academic cooperative groups to study amcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer

Sanofi launches €3 million Planet Mobilization fund to support employees’ environmental projects

Sanofi provides update on venglustat clinical program

Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate

Libtayo® (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers

Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting

Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer

Pivotal data at ATS 2021 show Dupixent® (dupilumab) significantly reduced asthma attacks and improved lung function in children

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

New data to be featured at EHA 2021 Congress highlight Sanofi’s ongoing commitment to rare blood disorders

Positive Phase 3 Libtayo® (cemiplimab) results in advanced cervical cancer presented at ESMO Virtual Plenary

Sanofi establishes three-year collaboration with Stanford Medicine to accelerate immunology research

Annual General Meeting of April 30, 2021

Final results of the Offer for Kiadis: 97.39% of Kiadis Shares in total committed under the Offer

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Delisting of Kiadis will be effective on 25 May 2021

Sanofi to help manufacture Moderna COVID-19 vaccine, supporting global supply demands

Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

Sanofi completes Kiadis acquisition

Sanofi declares the offer for Kiadis unconditional

Sanofi to invest in a leading-edge production site in Singapore; continues to strengthen its vaccines manufacturing capacities

Sanofi acquires Tidal Therapeutics, adding innovative mRNA-based research platform with applications in oncology, immunology, and other disease areas

Sanofi completes Kymab acquisition

Interim late-breaking clinical data validate not-alpha profile of THOR-707 (SAR444245), Sanofi’s novel investigational IL-2

Positive results from the sutimlimab pivotal trial for people with cold agglutinin disease published in New England Journal of Medicine

Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines

FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma

Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine

Sanofi continues streamlining of established products with sale of anti-inflammatory drugs to Fidia Farmaceutici

Availability of the Q1 2021 Memorandum for modelling purposes

Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival           

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

Filing of the 2020 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

Sanofi’s Board of Directors proposes the appointment of Christian Brandts and Barbara Lavernos as Board Members

CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma

FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate

Sanofi to provide manufacturing support to Johnson & Johnson for their COVID-19 vaccine to help address global supply demands

Efanesoctocog alfa granted FDA Fast Track Designation for treatment of hemophilia A

The Lancet publishes Libtayo® (cemiplimab) data showing extended overall survival in patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

Sanofi launches recommended cash offer for all shares in Kiadis

Offer Memorandum for All Outstanding Shares of Kiadis Pharma N.V.

FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma

New indication for Plavix® (clopidogrel) now approved in the European Union

Sanofi presents amended protocols in fitusiran clinical studies at EAHAD 2021

Capital Markets Day 2021: Sanofi progresses on its strategy to drive growth across its businesses and innovation with emerging leadership in immunology

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Kiadis shareholders give irrevocable commitment to tender 36.6% of the shares under the offer by Sanofi

 Data presented at WORLDSymposiumTM reinforces robust rare disease pipeline and highlights additional clinical data for investigational avalglucosidase alfa in Pompe disease

New Dupixent® (dupilumab) data showcasing improvements across four type 2 inflammatory diseases to be presented at 2021 AAAAI Annual Meeting

Sanofi to provide support to BioNTech in manufacturing their COVID-19 vaccine to help address public health needs

SANOFI unveils EUROAPI as the name of the new industry leading European API* company and appoints Karl Rotthier as its future Chief Executive Officer

Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L