Drugs in Dev. Immunology
Phase III
Australia 
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Gregory George
Deal Size : $50.0 million
Deal Type : Financing
Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch
Details : The proceeds will be used in Mesoblast’s lead product candidate Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD).
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
September 29, 2024
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Gregory George
Deal Size : $50.0 million
Deal Type : Financing
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts BLA for Mesoblast’s Ryoncil® in Pediatric Acute Graft-Versus-Host Disease
Details : Ryoncil (remestemcel-l) have immunomodulatory properties to counteract the inflammatory processes in SRaGVHD by down-regulating the production of pro-inflammatory cytokines.
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
July 23, 2024
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Mesoblast Resubmits BLA for Ryoncil® in Children with Steroid-Refractory aGVHD
Details : Ryoncil (remestemcel-L) is an investigational therapy comprising mesenchymal stromal cells, for the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD).
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
July 09, 2024
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Maolactin
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Maolactin is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Inflammatory Diseases.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 06, 2024
Lead Product(s) : Maolactin
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Maolactin
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Maolactin is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Post Exercise Inflammation.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
May 31, 2024
Lead Product(s) : Maolactin
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Notifies Mesoblast That Phase 3 Data Supports BLA for SR-aGVHD in Children
Details : Prochymal (remestemcel-L) is an off-the-shelf suspension of ex-vivo cultured adult human mesenchymal stem cells, evaluated for pediatric patients with SR-aGVHD.
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
March 25, 2024
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : BMT CTN
Deal Size : Undisclosed
Deal Type : Agreement
Details : 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).
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
November 21, 2023
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : BMT CTN
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval
Details : 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...
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
September 21, 2023
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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.
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
August 03, 2023
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : $40.0 million
Deal Type : Private Placement
Mesoblast Completes Private Placement
Details : 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).
Product Name : Ryoncil
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
April 25, 2023
Lead Product(s) : Remestemcel-L
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : $40.0 million
Deal Type : Private Placement
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