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    Find Immunology Drugs in Phase III Clinical Development in AUSTRALIA

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              Mesoblast

              • Development Update

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              AUSTRALIA Australia

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              Mesoblast Receives Complete Response Letter From the FDA for its BLA for Steroid-Refractory Acute Graft Versus Host Disease in Children

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              Lead Product(s): Remestemcel-L

              Therapeutic Area: Immunology Product Name: Ryoncil

              Highest Development Status: Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 01, 2020

              Details:

              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.

              Mesoblast

              • Development Update

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              AUSTRALIA Australia

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              U.S. FDA Advisory Committee Votes in Favor of Ryoncil for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease

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              Lead Product(s): Remestemcel-L

              Therapeutic Area: Immunology Product Name: Ryoncil

              Highest Development Status: Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 14, 2020

              Details:

              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.

              Mesoblast

              • Development Update

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              AUSTRALIA Australia

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              Clinical Outcomes Using RYONCIL in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles

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              Lead Product(s): Remestemcel-L

              Therapeutic Area: Immunology Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 25, 2020

              Details:

              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.