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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Reports on Mesoblast Ltd.

 PRESS RELEASE

Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and ...

Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast's data on opioid reduction and cessation from its first Phase 3 study (MSB-DR003) of rexlemestrocel-L in patients with chronic low back pain (CLBP). In Mesoblast's first randomized controlled Phase 3 trial of 404 patients...

 PRESS RELEASE

Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch

Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch Activity Report for Quarter Ended September 30, 2025 (Appendix 4C) NEW YORK, Oct. 19, 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 first quarter ended September 30, 2025. Mesoblast Chief Executive Dr. Silviu Itescu said, “Revenues from sales of Ryoncil® continue to increase, driven by greater physician adoption with reimbursement from both commercial and government paye...

 PRESS RELEASE

Ryoncil® Revenues Increase 66% in Second Quarter Post Launch

Ryoncil® Revenues Increase 66% in Second Quarter Post Launch NEW YORK, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue of US$21.9 million on Ryoncil® (remestemcel-L-rknd) sales for the quarter ended September 30, 2025. This represents a 66% increase on the prior quarter ended June 30, 2025, with similar gross to net adjustment. Ryoncil® is the first mesenchymal stromal cell (MSC) product by the U.S. Food and Drug Administration (FDA) for any indication, and...

 PRESS RELEASE

Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facil...

Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025.1 Formal recognition by CMS is a significant milestone for Ryoncil® as...

 PRESS RELEASE

Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Sub...

Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy by U.S. Food and Drug Administration (FDA...

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