Mesoblast

MESO

時価総額 $17.2億

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.

Mesoblast Limited (NASDAQ:MESO) stock is trading higher on Monday after the company concluded patient dosing for its crucial Phase 3 clinical trial evaluating rexlemestrocel-L.

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.

Expanding indications for RYONCIL in children and adults with life-threatening inflammatory diseases Achieved target of at least 300 Patients treated in Pivotal Phase 3 trial for Chronic Low Back Pain Activity Report for Quarter Ended June 30, 2026 (Appendix 4C) NEW YORK, July 29, 2026 (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 fourth fiscal quarter ended June 30, 2026. “We are very pleased with the continued momentum in uptake of Ryoncil® in children with life-threatening steroid-refractory acute GvHD across major U.S. pediatric centers, positioning the treatment well for use next in adults with this life-threatening disease.

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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.