MSB Mesoblast Ltd.

Randomized Controlled Phase 3 Trial of Remestemcel-L for Reduced Mortality in COVID-19 Acute Respiratory Distress Syndrome Surpasses 50% Enrollment

Randomized Controlled Phase 3 Trial of Remestemcel-L for Reduced Mortality in COVID-19 Acute Respiratory Distress Syndrome Surpasses 50% Enrollment
EN
13/10/2020

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MSBMesoblast Ltd.

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Reports on Mesoblast Ltd.

 PRESS RELEASE
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MSB MESOBLAST LTD.

Mesoblast and FDA Align on Key Items for Revascor® Biologic License Ap...

Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation. In follow-up to the successful Type B ...

July 1, 2025 1 EN
 PRESS RELEASE
Free
MSB MESOBLAST LTD.

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway ...

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF...

June 12, 2025 1 EN
 PRESS RELEASE
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MSB MESOBLAST LTD.

FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil...

FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil® NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another m...

May 15, 2025 1 EN
 PRESS RELEASE
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MSB MESOBLAST LTD.

Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025

Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025 NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third quarter ended March 31, 2025. “We were very pleased to have made Ryoncil® (remestemcel-L) commercially available to treat children with acute GVHD within one quarter of receiving FDA approval as the first mesenchymal stromal cell (MSC) therapy in the US for any indication,” said Dr. Silviu Itesc...

April 30, 2025 1 EN
 PRESS RELEASE
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MSB MESOBLAST LTD.

Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board

Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Lyn Cobley to its Board of Directors. Ms. Cobley has been a global leader in the financial services industry with over 30 years’ experience in senior positions at international and domestic banks. Ms. Cobley has served as CEO of Westpac Institutional Bank, Group Treasurer of Commonwealth Bank of Australia, and held senior roles at Barclay...

April 28, 2025 1 EN

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