CSBio CSBio

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molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"ARS Pharmaceuticals"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR\u00ae (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Kashiv BioSciences"},{"orgOrder":0,"company":"ARS Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U.S. FDA for Neffy\u00ae (epinephrine nasal spray)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"ARS Pharmaceuticals"},{"orgOrder":0,"company":"ALK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Large Phase 3 Clinical Trial Successfully 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III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"MaaT Pharma"},{"orgOrder":0,"company":"InnoCare Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InnoCare Announces First Patient Dosed in the Phase III Registrational Trial of Orelabrutinib for the Treatment of ITP in China","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"InnoCare 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"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Data Show Potential of Remibrutinib as an Oral Treatment for Chronic Spontaneous Urticaria Providing Significant Symptom Improvement as Early as Week 2","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"Medeor Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medeor Therapeutics Announces Interim Data from Pivotal Trial Showing Cell Therapy Technology Could Eliminate Life-Long Need for Immunosuppressant Drugs Following Kidney Transplant","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Medeor Therapeutics"},{"orgOrder":0,"company":"X4 Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular 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Status","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"HONG KONG","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Hutchmed"},{"orgOrder":0,"company":"Viridian Therapeutics","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Viridian Therapeutics Announces Pricing of Public Offering of Shares of Common Stock","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Viridian Therapeutics"},{"orgOrder":0,"company":"ALK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ALKs European Registration Application for House Dust Mite SLIT-tablet in Young Children Accepted for Review","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"ALK"},{"orgOrder":0,"company":"ARS Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of Neffy\u00ae (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA's Complete Response Letter","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"ARS Pharmaceuticals"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not 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2024","url1":"","url2":"","graph1":"Large molecule","graph2":"aTyr Pharma"},{"orgOrder":0,"company":"Incyte Corporation","sponsor":"Syndax Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Incyte Corporation"}]

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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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            DRL_RI is being developed as a biosimilar of Rituxan/MabThera (rituximab), a CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and pemphigus vulgaris.

            Lead Product(s): Rituximab

            Therapeutic Area: Immunology Product Name: DRL_RI

            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 July 12, 2023

            Details:

            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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            SELECT-AXIS 2 highlights efficacy and safety data of upadacitinib (RINVOQ®) in patients with non-radiographic axial spondyloarthritis, and in patients with radiographic axial spondyloarthritis with an inadequate response to biologic disease-modifying antirheumatic drugs.

            Lead Product(s): Upadacitinib

            Therapeutic Area: Immunology Product Name: Rinvoq

            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 May 24, 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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            Submissions supported by Phase 3 study in which upadacitinib (RINVOQ®) demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo.

            Lead Product(s): Upadacitinib

            Therapeutic Area: Immunology Product Name: Rinvoq

            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 January 07, 2022

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            CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2 studies of SKYRIZI® (risankizumab), an interleukin-23 (IL-23) inhibitor for treatment of chronic immune-mediated diseases.

            Lead Product(s): Risankizumab

            Therapeutic Area: Immunology Product Name: Skyrizi

            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 October 15, 2021

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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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