Immunology | Phase III Developments | AUSTRALIA

Mesoblast

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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

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

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

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.

Mesoblast

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Fda Accepts Mesoblast’s Biologics Licence Application For Ryoncil™ And Agrees To Priority Review

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 April 01, 2020

Details:

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

Mesoblast

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Mesoblast Submits Clinical Efficacy And Safety Data To FDA In Rolling Biologics License Application For Remestemcel-L

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 January 02, 2020

Details:

The data shows effectiveness of remestemcel-L in children with SR-aGVHD, with particular efficacy and survival benefit in patients with the most severe forms of aGVHD.

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Mesoblast

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

Mesoblast

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

Mesoblast

Fda Accepts Mesoblast’s Biologics Licence Application For Ryoncil™ And Agrees To Priority Review

Mesoblast

Mesoblast Submits Clinical Efficacy And Safety Data To FDA In Rolling Biologics License Application For Remestemcel-L