Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis Sep 9, 2020 Sanofi Genzyme continues research to improve the lives of patients with multiple sclerosis, with new data presented at MSVirtual2020 - New data on investigational brain-penetrant BTK inhibitor tolebrutinib (SAR442168) further support its potential in modulating disabling inflammatory processes within the central nervous system 2020-05-28 MMMM DD YYYY.

If data are positive, regulatory approval could be achieved by the first half of 2021. Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformation. Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/ 2 study to start in September, followed by a Phase 3 study by the end of 2020. ... Read the article.

Sanofi announces closing of Regeneron stock sale. FDA accepts for priority review Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival Sanofi at forefront of fight against COVID-19 in Q1 2020Sanofi brain-penetrant BTK inhibitor significantly reduced disease activity in phase 2 trial in relapsing multiple sclerosis Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosisDupixent® (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 yearsFirst patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19 Sanofi receives positive CHMP opinion for Sarclisa® (isatuximab) for the treatment of relapsed and refractory multiple myelomaFDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma By continuing to browse this website, you agree to the use of such cookies.FDA grants Dupixent® (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitisNew England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia ADupixent® (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidateSanofi provides update on Kevzara® (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S.Sanofi to commence tender offer for acquisition of Principia Biopharma Inc. Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccineSanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccineNirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trialOnline availability of Sanofi’s half-year financial report for 2020Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformationSanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccineAvailability of the Pre-quarterly Results CommunicationSanofi and Regeneron provide update on Kevzara® (sarilumab) Phase 3 U.S. trial in COVID-19 patientsSanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patientsSanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areasSanofi announces positive long-term efficacy and safety data for fitusiran from interim analysis of Phase 2 extension study in people with hemophilia A and B, with or without inhibitors Dupixent® (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitisSanofi’s investigational enzyme replacement therapy shows clinically meaningful improvement in critical manifestations of late-onset Pompe diseaseSanofi invests to make France its world class center of excellence in vaccine research and productionSanofi to present growth opportunities and development strategy for Dupixent® (dupilumab) in type 2 inflammatory diseasesSanofi to present Phase 3 results of avalglucosidase alfa in patients with late-onset Pompe diseaseSanofi to launch “Action 2020”, a worldwide employee stock purchase planSarclisa® (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myelomaEuropean Commission approves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myelomaSanofi to present oncology strategy, provide update on portfolio and emerging pipelineLibtayo® (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over timeSanofi’s Board of Directors notes the resignation of Emmanuel Babeau and coopts Gilles Schnepp as Independent DirectorSanofi announces pricing of Regeneron stock offeringSanofi: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitisSanofi intends to sell its equity investment in Regeneron; confirms no change to ongoing collaborationDupixent® (dupilumab) eosinophilic esophagitis trial meets both co-primary endpointsSanofi to highlight pipeline programs in a series of interactive virtual sessions leading to a R&D day eventFDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin DiseaseSarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myelomaLibtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinomaSanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survivalSanofi and Regeneron provide update on U.S. Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Press releases. Avalglucosidase alfa showed positive exploratory efficacy and was well-tolerated in Phase 2 trials in Pompe Disease

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