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[{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with Peanut Allergy","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Provides Update on Viaskin Peanut BLA for Children Ages 4-11 Years","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Undisclosed","date":"March 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"ElsaLys Biotech","sponsor":"Mediolanum Farmaceutici","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mediolanum Farmaceutici Acquires the French Company ElsaLys Biotech to Develop Next Generation Immuno-oncology Therapies","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"ElsaLys Biotech"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Principia Announces AAD Late Breaker Research Presentation of its Pemphigus Phase 2 Part B Trial","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi Gets Priority FDA Review for Sutimlimab Product","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies to Present Data on Epicutaneous Immunotherapy and Food Allergy Quality of Life at EAACI Digital Congress 2020","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Undisclosed","date":"June 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Principia Announces Positive Data from its Phase 2 Part B Trial in Pemphigus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Publishes PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Undisclosed","date":"July 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"ElsaLys Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ElsaLys Biotech Submits Biologics License Application to FDA for LEUKOTAC for the treatment of graft-versus-host disease in adult patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"ElsaLys Biotech"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Long Journey for DBV Peanut Patch Ends in Rejection by FDA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Undisclosed","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$3,680.0 million","upfrontCash":"$3,680","newsHeadline":"Sanofi to acquire Principia Biopharma","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Announces Filing and Validation of Marketing Authorization Application for Viaskin\u2122 Peanut by European Medicines Agency","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies to Highlight Data on Viaskin\u2122 Peanut Treatment Delivery and Patient Experience at ACAAI 2020","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Undisclosed","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Fast Track Designation to BTK Inhibitor, Rilzabrutinib to Treat Immune Thrombocytopenia","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Patient Enrollment Concluded Early in PEGASUS Phase 3 Pemphigus Trial for Rilzabrutinib","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Results from Sanofi's Sutimlimab Pivotal Trial for People with Cold Agglutinin Disease Published in New England Journal of Medicine","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Announces a Voluntary Hold in the Clinical Studies of Masitinib Worldwide","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"orgOrder":0,"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science is Providing a Summary of the Live Webcast Held on June 3, 2021 Following the Voluntary Hold in the Clinical Studies of Masitinib","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"orgOrder":0,"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Pivotal Data at EHA 2021 reinforces Sutimlimab as A First-in-Class Investigational C1s Inhibitor","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi Provides Update on Phase 3 Study Evaluating Rilzabrutinib for the Treatment of Pemphigus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small 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molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MaaT Pharma to Present Promising Clinical Data for Lead Therapeutic Candidate MaaT013 at 48th EBMT Annual Meeting","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MaaT Pharma Announces First Patient Dosed in Phase 3 \u2018ARES\u2019 Trial Evaluating MaaT013 in Patients with Acute Graft-vs-Host-Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Phase 1\/2 Study Results of Rilzabrutinib in People With Immune Thrombocytopenia Published in the New England Journal of Medicine","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"INRAE","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"INRAE and MaaT Pharma Build on the Success of their Long-Standing Partnership with the Entry of Drug-Candidate MaaT013 into Phase 3 Clinical Trial","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi, a Leader in Immune-mediated Rare Blood Disorders, to Present Latest Data at EHA 2022","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"Medsenic","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medsenic Publishes an Article in Transplantation and Cellular Therapy, Unveiling High Response Rate and Corticosteroid Sparing With Arsenic Trioxide-based First-line Therapy in cGvHD after allo-HSCT","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Medsenic"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MaaT Pharma Announces Update on U.S. FDA Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Announces Initiation of Phase 3 Study (VITESSE) Using the Modified Viaskin Peanut Patch in Peanut -Allergic Children Ages 4 to 7 Years","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MaaT Pharma Receives U.S. FDA Response Outlining Path Forward for Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease and Reports Cash and Revenues for Fourth Quarter 2022","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Announces First Patient Screened in VITESSE Phase 3 Clinical Trial in Peanut-Allergic Children 4 -7 Years Old","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 \u2013 3 Years After Receiving Pre-BLA Responses from FDA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV 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molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Sanofi"},{"orgOrder":0,"company":"MaaT Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MaaT Pharma Announces Positive Outcome Following DSMB Review Reinforcing Confidence in Phase 3 On-Going Trial in Acute Graft-versus-Host Disease with MaaT013","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"DBV Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"DBV Technologies"}]

Find Immunology Drugs in Phase III Clinical Development in FRANCE

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            Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13), and US FDA has issued a CRL for the sBLA for Dupixent® (dupilumab) in chronic spontaneous urticaria (CSU).

            Lead Product(s): Dupilumab

            Therapeutic Area: Immunology Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 20, 2023

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            PRN1008 (rilzabrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY® technology being investigated for the treatment of immune-mediated diseases, including ITP.

            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: PRN1008

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2022

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            Rilzabrutinib is an investigational oral Bruton tyrosine kinase inhibitor (BTKi) for the treatment of ITP, a rare acquired autoimmune disorder in which platelets are destroyed or damaged and for which there are limited treatment options.

            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: PRN1008

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 14, 2022

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            In a Phase 3 trial in patients refractory to omalizumab, Dupixent did not reach statistical significance in an interim analysis despite numeric improvements observed across key endpoints; trial will be stopped due to futility.

            Lead Product(s): Dupilumab

            Therapeutic Area: Immunology Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 18, 2022

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            Rilzabrutinib is a potential first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor in development for immune-mediated diseases. Rilzabrutinib’s safety profile remained consistent with previous results and no new safety signals were identified.

            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: PRN1008

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 09, 2021

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            The CADENZA trial is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of sutimlimab in patients with CAD without a recent history of blood transfusion (within the past 6 months).

            Lead Product(s): Sutimlimab

            Therapeutic Area: Immunology Product Name: BIVV009

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2021

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            Data from the pivotal Phase 3 CARDINAL study demonstrated sutimlimab inhibited C1-activated hemolysis (abnormal destruction of healthy red blood cells) within one week of treatment and had a sustained treatment effect over the course of the study.

            Lead Product(s): Sutimlimab

            Therapeutic Area: Immunology Product Name: BIVV009

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2021

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            PEGASUS is a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial enrolling approximately 120 participants to evaluate rilzabrutinib versus placebo, using a background treatment of tapering doses of corticosteroids (CS).

            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: PRN1008

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 24, 2020

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            In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.

            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: PRN1008

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2020

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            The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.

            Lead Product(s): Sutimlimab

            Therapeutic Area: Immunology Product Name: BIVV009

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 14, 2020

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