MESO

NEW YORK, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received approval from the United States Food and Drug Administration (FDA) to implement a new potency assay, T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of all new commercial product lots of its FDA-approved mesenchymal stromal cell (MSC) product Ryoncil® (remestemcel-L-rknd).

Mesoblast Limited (MESO) Q4 2026 Earnings Call Transcript

RYONCIL Market Share Expands; Phase 3 Back Pain Trial Completes Treatment Financial Results and Operational Update for Full Year Ended June 30, 2026 NEW YORK, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended June 30, 2026 (FY2026). Chief Executive of Mesoblast Dr. Silviu Itescu, commented on the result: “We are very pleased to report a strong full year gross profit of US$104M for the fiscal year 2026.

Mesoblast NASDAQ: MESO reported $115 million in net revenue for fiscal 2026, its first full year of commercial sales for RYONCIL, the company's FDA-approved allogeneic mesenchymal stromal cell therapy for children with steroid-refractory acute graft-versus-host disease, or GVHD.

Mesoblast rises after completing treatment of 350 patients in a pivotal phase III study of rexlemestrocel-L for treating chronic low back pain.

NEW YORK, Aug. 16, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has completed patient treatment in the MSB-DR004 pivotal randomized controlled Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease. The major milestone was achieved with 350 patients randomized and treated with either an intra-discal injection of rexlemestrocel-L or sham injection. Total patient numbers treated increased from 300 to 350 after strong demand from trial investigators to have their patients enrolled in the innovative program.

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NEW YORK, July 13, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has achieved its target of at least 300 patients treated in the MSB-DR004 pivotal Phase 3 randomized controlled trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease. The trial aims to confirm the durable pain reduction from a single intra-discal injection of rexlemestrocel-L seen in the earlier MSB-DR003 trial.

NEW YORK, July 09, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net revenue of US$36 million for the quarter and US$115 million for the full year ended June 30, 2026. “We are very pleased with the strong uptake of Ryoncil® since launch, and with revenues that have already exceeded our initial projections,” said Mesoblast Chief Executive Dr. Silviu Itescu.

NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). Rexlemestrocel-L has received Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and has Regenerative Medicine Advanced Therapy (RMAT) designation for this patient population, providing eligibility for rolling and priority reviews of the BLA.