Mesoblast Achieves Target of 300 Treated Patients in Pivotal Phase 3 Trial for Chronic Low Back Pain

2026-07-13 20:35:00

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.

Mesoblast: The Commercial Proof Is Now Becoming The Investment Thesis

2026-07-11 07:59:12

Mesoblast transitions to a commercial-stage company, anchored by FDA-approved Ryoncil and robust early revenue growth. Ryoncil's regulatory, reimbursement, and manufacturing precedents de-risk MESO's broader mesenchymal lineage platform and future label expansions. Cash burn has decreased, non-dilutive funding strengthens the balance sheet, and pipeline progress supports a platform premium valuation.

Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026

2026-07-09 20:30:00

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.

Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs

2026-06-30 20:38:00

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.

Mesoblast Draws US$50 Million from Five-Year Non-Dilutive Facility

2026-06-24 20:59:00

Optimized capital structure, retiring short-term maturing debt Well-funded for commercial operations and growth pipeline NEW YORK, June 24, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it drew down US$50 million from its five-year facility provided by existing Mesoblast shareholder and director Dr. Gregory George. Mesoblast had US$122 million cash at March 30, 2026.

Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million

2026-04-29 20:55:01

Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain Activity Report for Quarter Ended March 31, 2026 (Appendix 4C) NEW YORK, April 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 third fiscal quarter ended March 31, 2026.

Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million

2026-04-29 20:55:00

Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain Activity Report for Quarter Ended March 31, 2026 (Appendix 4C) NEW YORK, April 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 third fiscal quarter ended March 31, 2026. “We've had a busy and exciting March quarter marked by a series of major achievements.

Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain

2026-04-28 20:53:00

NEW YORK, April 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its pivotal Phase 3 clinical trial evaluating rexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated with degenerative disc disease has achieved its patient recruitment target. This marks a significant milestone in Mesoblast's plans for commercialization of rexlemestrocel-L, its proprietary allogeneic stromal cell therapy targeting inflammatory processes underlying disc degeneration.