[{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mesoblast Submits Clinical Efficacy And Safety Data To FDA In Rolling Biologics License Application For Remestemcel-L","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fda Accepts Mesoblast\u2019s Biologics Licence Application For Ryoncil\u2122 And Agrees To Priority Review","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Clinical Outcomes Using RYONCIL in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Advisory Committee Votes in Favor of Ryoncil for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mesoblast Receives Complete Response Letter From the FDA for its BLA for Steroid-Refractory Acute Graft Versus Host Disease in Children","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Children Treated With Remestemcel-L Show Long-Term Survival Through Four Years in Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Mesoblast\u2019s Resubmission of The Biologic License Application for Remestemcel-L in Children with Steroid-Refractory Acute Graft versus Host Disease as A Complete Response and Sets Goal Date of August 2, 2023","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"Mesoblast Completes Private Placement","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"orgOrder":0,"company":"Mesoblast","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mesoblast Receives Complete Response from U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"},{"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":"Mesoblast","sponsor":"BMT CTN","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mesoblast Partners with Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults with SR-aGVHD","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Mesoblast"}]
Find Immunology Drugs in Phase III Clinical Development in AUSTRALIA
The agreement aims to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil (remestemcel-L) in the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD).
Ryoncil (remestemcel-l) have immunomodulatory properties to counteract the inflammatory processes in SRaGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of naturally occurring anti-inflammatory cells to involved tissues.
Remestemcel-L have immunomodulatory properties to counteract the inflammatory processes in SRaGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of naturally occurring anti-inflammatory cells to involved tissues.
The net proceedings will be used to fund the launch and commercialization of the company’s lead product, Prochymal (remestemcel-L), in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Remestemcel-L have immunomodulatory properties to counteract the inflammatory processes in SRaGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of naturally occurring anti-inflammatory cells to involved tissues.
Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SRaGVHD by down-regulating pro-inflammatory cytokines, increasing production of antiinflammatory cytokines.
Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome.
While the ODAC of the FDA voted that the available data support the efficacy of remestemcel-L in children with SR-aGVHD, the FDA suggests that Mesoblast conduct at least one more study in adults and/or children to provide further proof of the effectiveness of remestemcel-L.
Oncologic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL™) in pediatric patients with steroid-refractory acute graft versus host disease.
Trial results underpin Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL for pediatric steroid-refractory acute graft versus host disease, which has been accepted for priority review by the USFDA.