Mesoblast Limited

301 articles about Mesoblast Limited

• Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease

  11/26/2023

  Mesoblast Limited announced that it has filed for orphan drug designation and rare pediatric disease designation with the United States Food and Drug Administration for its allogeneic cell therapy Revascor® in the treatment of the congenital heart disease hypoplastic left heart syndrome.

• Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2023

  10/31/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the first quarter ended September 30, 2023.

• Jane Bell AM Appointed Chair of Mesoblast Audit and Risk Committee

  9/26/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that independent Director Jane Bell AM has been appointed Chair of the Mesoblast Board Audit and Risk Committee.

• 

  FDA Regulatory Gauntlet Isn’t Getting Any Easier, Just Ask These Companies

  9/22/2023

  ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
• 

  Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting

  9/21/2023

  Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.

• Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval

  9/21/2023

  Mesoblast Limited provided an update on the path to approval for its lead-product candidate remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease, following a Type A meeting held with the United States Food and Drug Administration.

• 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

  8/4/2023

  Mesoblast Limited announced that the US Food and Drug Administration has provided a complete response to its Biologics License Application resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease and requires more data to support marketing approval.

• 

  FDA Blocks Mesoblast Cell Therapy Again, Asks for More Data

  8/4/2023

  For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.

• Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2023

  7/31/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the fourth quarter ended June 30, 2023.

• Mesoblast Director Philip R. Krause, M.D., Appointed to Strategic Advisory Role

  6/5/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, is pleased to announce that it has appointed Dr. Philip R. Krause, a member of the Board of Directors, to a formal strategic advisory role.

• Mesoblast Reports Operational and Financial Highlights for Quarter Ended March 31, 2023

  5/25/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, reported operational highlights and financial results for the period ended March 31, 2023.

• Appendix 4C Quarterly Activity ReportMesoblast Financial and Operational Highlights for Quarter Ended March 31, 2023

  4/28/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the third quarter ended March 31, 2023.

• Mesoblast Completes Private Placement - April 26, 2023

  4/26/2023

  Mesoblast Limited announced it has completed a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs, at A$0.85 per share.

• FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing

  3/22/2023

  Mesoblast Limited announced that, as part of the ongoing review of the BLA for remestemcel-L in the treatment of children with SR-aGVHD, the United States Food and Drug Administration has scheduled a Pre-License Inspection of Mesoblast’s cell therapy manufacturing operations at Lonza Bioscience in Singapore.

• 

  FDA Accepts Mesoblast’s Ryoncil Resubmission for Pediatric GVHD 

  3/8/2023

  Three years after the FDA rejected its initial biologic license application, Mesoblast announced its resubmission for Ryoncil. Now, the treatment is getting a second chance.

• FDA Accepts Mesoblast’s 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

  3/8/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration’s Office of Therapeutic Products has accepted the Company’s Biologics License Application resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.

• Mesoblast Reports Operational and Financial Highlights for Quarter Ended December 31, 2022

  2/27/2023

  Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the period ended December 31, 2022.

• Mesoblast Financial Results and Corporate Update Webcast - February 27, 2023

  2/27/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the second quarter ended December 31, 2022.

• DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology (JACC)

  2/27/2023

  Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology.

• Remestemcel-L Clinical and Potency Studies Presented at Premier Meeting of Transplantation Research and Therapy

  2/16/2023

  Mesoblast Limited announced that two studies on the remestemcel-L development program for the treatment of children with steroid-refractory acute graft versus host disease were selected by peer review to be presented at the 2023 Tandem Meetings of the American Society for Transplantation and Cellular Therapy and the Center for Blood and Marrow Transplant Research, taking place February 15-19 in Orlando, Florida.