MESO

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.

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.

NEW YORK, April 14, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has acquired an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic mesenchymal lineage stromal cell (MSC) products. Mesoblast plans to incorporate the engineered CARs to further boost effectiveness of Mesoblast's products, with the goal of enhancing the target specificity and augmenting inherent properties of immunomodulation and tissue regeneration.

Working with Parent Project Muscular Dystrophy and the Duchenne Registry on patient identification and trial awareness efforts

Mesoblast Limited (MESO) Discusses Cellular Medicine Platforms and Innovations at R&D Day Transcript

Mesoblast (MESO) is upgraded to a speculative Buy as Ryoncil outperforms in pediatric SR-aGVHD and advances rapidly into a registrational DMD trial. Ryoncil's DMD opportunity is underappreciated, with a modeled $2B peak sales and $1.18B risk-adjusted NPV, enabled by FDA confidence in its safety profile. SR-aGVHD remains a niche but high-margin market, with Ryoncil nearing $100M in sales and strong launch adoption, though adult expansion faces competition.

Mesoblast outlines commercial strategy to double net revenues as Ryoncil ® approaches US$100M net revenue milestone since launch last year

Partnering with Parent Project Muscular Dystrophy to ensure timely access to the trial for eligible patients ~15,000 children are living with DMD in the U.S. NEW YORK, April 07, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to directly proceed for a registrational clinical trial evaluating Ryoncil® (remestemcel-L-rknd) in Duchenne muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S.1 Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by FDA, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD)2. This new registrational trial builds on Ryoncil's® proven safety in children, evidence of efficacy in DMD preclinical models, and FDA-approved manufacturing process.

Strong growth in February/March following January seasonality Net revenue approaches US$100M since launch NEW YORK, April 06, 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 sales were US$30.3 million for the quarter ended March 31, 2026.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million.