Welcome to our dedicated page for Mesoblast news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Mesoblast Limited develops allogeneic cellular medicines for severe inflammatory conditions through a proprietary mesenchymal lineage cell therapy platform. Its commercial and pipeline updates center on Ryoncil® (remestemcel-L-rknd), an FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, and on additional cell therapy programs for chronic low back pain, heart failure, Duchenne muscular dystrophy and inflammatory or autoimmune diseases.
Recurring company news covers Ryoncil launch and revenue trends, clinical and regulatory developments involving rexlemestrocel-L and Ryoncil label-extension programs, FDA clearances and designations, R&D presentations, technology licensing and platform expansion such as CAR-engineered MSC products, and quarterly cash-flow reporting filed with the Australian Securities Exchange.
Mesoblast (Nasdaq:MESO; ASX:MSB) announced it has reached its target of at least 300 treated patients in the MSB-DR004 pivotal Phase 3 randomized, placebo-controlled trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease.
The trial aims to confirm durable pain reduction from a single intra-discal injection seen in the earlier MSB-DR003 study. The primary endpoint is reduction in low back pain at 12 months versus sham control, with secondary endpoints including function, quality of life, and cessation of pain medication, including opioids. Rexlemestrocel-L has RMAT designation from the FDA, enabling eligibility for priority review once a BLA is filed. Mesoblast is progressing commercial manufacturing in parallel, with top-line Phase 3 results expected in mid‑CY2027. The CLBP indication is described by Mesoblast as a potential blockbuster with possible peak year revenue >US$10 billion at single-digit market penetration.
Mesoblast (Nasdaq:MESO; ASX:MSB) reported preliminary net revenue from Ryoncil® (remestemcel-L-rknd) of US$36 million for the quarter and US$115 million for the first full year ended June 30, 2026. Management said revenues have exceeded initial projections and that they expect revenue growth to continue in the next fiscal year, supported by momentum across major U.S. pediatric centers.
According to Mesoblast, the company’s capital position is strong and operational activities are well funded through revenue growth, with a new five-year facility supporting strategic initiatives for label extensions and potential blockbuster products. Ryoncil is described as the first mesenchymal stromal cell product approved by the U.S. FDA for any indication and the only FDA-approved therapy for children under 12 with steroid-refractory acute graft-versus-host disease. The revenue figures are based on management’s preliminary estimates and remain subject to customary year-end closing and audit procedures.
Mesoblast (Nasdaq:MESO) received a U.S. FDA Biologics License Application (BLA) filing number and requested modular review for rexlemestrocel-L in preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients with LVADs.
The therapy holds Orphan Drug and RMAT designations, aligning with recent FDA guidance on flexible evidence and CMC requirements for cellular and gene therapies.
Mesoblast (Nasdaq:MESO) drew US$50 million from a five-year, non-dilutive credit facility provided by shareholder and director Dr Gregory George. Mesoblast reported US$122 million in cash at March 30, 2026.
The facility carries fixed 8% interest, a five-year interest-only period, and is secured solely by the Temcell royalty. Proceeds are intended to retire higher-cost NovaQuest debt and remove short-term obligations without encumbering material assets or intellectual property.
Mesoblast (Nasdaq:MESO) reported Ryoncil net revenues of US$30.3m and gross sales US$35.3m for the quarter ended March 31, 2026. Net operating cash spend improved to US$4.1m, cash on hand was US$122m, and first-year Ryoncil sales approach US$100m.
Operationally, Mesoblast achieved patient recruitment for a pivotal Phase 3 CLBP trial, received FDA IND clearance for a registrational Ryoncil trial in DMD, began an SR-aGvHD label-extension trial, and licensed CAR technology for engineered MSCs.
Mesoblast (NASDAQ:MESO) announced its pivotal Phase 3 trial (MSB-DR004) of rexlemestrocel-L for chronic low back pain has met its patient recruitment target. The placebo-controlled study will randomize at least 300 patients to a single intra-discal injection or sham control with 12-month follow-up.
Top-line results are expected in mid-CY2027; a positive readout would support a planned regulatory filing in Q3 CY2027. Rexlemestrocel-L holds FDA RMAT designation for this indication.
Mesoblast (Nasdaq:MESO) acquired an exclusive worldwide license to a patented CAR technology platform to engineer chimeric antigen receptors into mesenchymal stromal cells (MSC) to enhance target specificity and potency.
The license, obtained via acquisition of a startup using ASX ordinary shares, includes Mayo Clinic in-kind support and GMP manufacturing collaboration to advance CAR-MSC products for inflammatory and autoimmune indications including ulcerative colitis, Crohn's disease and lupus nephritis.
Mesoblast (Nasdaq:MESO) received FDA Investigational New Drug (IND) clearance to proceed directly to a registrational trial evaluating Ryoncil (remestemcel-L-rknd) in Duchenne muscular dystrophy (DMD).
The randomized 76‑patient study will enroll boys aged 5–9, with 7 infusions (2x10^6 cells/kg) over nine months and a primary endpoint of time‑to‑stand at nine months.
Mesoblast (Nasdaq:MESO) outlined commercial and R&D advances at its inaugural R&D Day on April 8, 2026, targeting a plan to double net revenues while Ryoncil approaches a US$100 million cumulative net revenue milestone since last year’s launch.
Highlights include Phase 3 CLBP enrollment closing this month, an IRB-cleared adult SR-aGvHD trial with sites activating this quarter, an FDA-cleared IND to proceed to a registrational pediatric DMD trial, and acquisition of a Mayo Clinic–developed patented CAR platform to enhance its MSC products.
Mesoblast (Nasdaq: MESO) announced FDA IND clearance to proceed directly to a registrational trial of Ryoncil® in Duchenne muscular dystrophy (DMD) on April 7, 2026. The randomized trial will enroll 76 patients aged 5–9, dosing 7 infusions of 2 x 106 cells/kg over 9 months, with time-to-stand at nine months as the primary endpoint. Mesoblast cites Ryoncil’s approved pediatric safety profile in steroid-refractory aGvHD, preclinical DMD efficacy, an FDA-approved manufacturing process, and a collaboration with Parent Project Muscular Dystrophy to support enrollment.