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) reported FY2026 total revenue of US$120.3 million, up sharply from US$17.2 million a year earlier, driven by the first full U.S. commercial year of Ryoncil, which generated net product revenue of US$115.2 million after a 13.4% gross-to-net adjustment.
Reported gross profit was US$103.6 million, with gross profit excluding amortization of US$109.7 million versus US$16.0 million in FY2025. The net loss narrowed 44% to US$57.5 million, and net operating cash spend fell to US$43.8 million. Year-end cash was US$103 million, supported by a new US$125 million five-year non-dilutive credit facility that refinanced higher-cost debt. Operationally, Mesoblast expanded Ryoncil uptake across >50 U.S. pediatric transplant centers, advanced label expansion programs into adults with SR-aGvHD and children with Duchenne muscular dystrophy, completed treatment of 350 patients in a pivotal Phase 3 chronic low back pain trial of rexlemestrocel-L, and progressed a BLA for LVAD-associated gastrointestinal bleeding, while launching next-generation CAR-MSC and OV-MSC platform initiatives.
Mesoblast (Nasdaq:MESO, ASX:MSB) will host a webcast to review operational highlights and financial results for the full year ended June 30, 2026. The webcast begins at 6:30pm EDT on Wednesday, August 26 and 8:30am AEST on Thursday, August 27, 2026, accessible at https://webcast.openbriefing.com/msb-fyr-2026/, with an archived version on the company’s investor page.
Mesoblast develops allogeneic cellular medicines from its mesenchymal lineage cell therapy platform. Its product Ryoncil (remestemcel-L-rknd) is described as the first FDA-approved mesenchymal stromal cell therapy for pediatric SR-aGvHD, and the company advances additional indications and candidates including rexlemestrocel-L.
Mesoblast (Nasdaq:MESO; ASX:MSB) reported completion of patient treatment in its pivotal randomized, controlled Phase 3 MSB-DR004 trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease. A total of 350 patients were randomized to receive either an intra-discal injection of rexlemestrocel-L or a sham injection, up from 300 after strong investigator demand.
The trial’s 12‑month primary endpoint is durable pain reduction from a single injection, aiming to confirm results seen in the earlier MSB-DR003 trial. Secondary endpoints include function, quality of life, and reduction or cessation of pain medication, including opioids. According to Mesoblast, with 350 treated patients the study is well-powered to detect greater benefit versus controls. Rexlemestrocel-L holds FDA RMAT designation for CLBP due to degenerative disc disease, making it eligible for priority review once a BLA is filed. Top-line Phase 3 results are expected in mid‑CY2027. Mesoblast estimates CLBP from degenerative disc disease affects over 7 million people in the U.S. and cites potential peak year revenue of more than US$10 billion for this indication at single-digit market penetration.
Mesoblast (Nasdaq:MESO; ASX:MSB) reported preliminary Ryoncil® net revenue of US$36 million for the June 2026 quarter and US$115 million for the first full year post-FDA approval, including US$66.5 million in the second half. Net operating cash spend for FY2026 was US$43.8 million, with US$13.4 million in the second half, and cash on hand was US$103 million after drawing US$50 million from a five-year facility to extinguish all maturing debt.
Operationally, Mesoblast is running a registrational trial to extend Ryoncil’s label to adults with steroid-refractory acute GvHD and received FDA IND clearance for a registrational trial in ambulatory children with Duchenne muscular dystrophy. The company also completed enrollment of at least 300 patients in a pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, obtained a BLA filing number and requested modular review for rexlemestrocel-L in LVAD-associated GI bleeding prevention, and licensed a CAR-MSC platform targeting inflammatory bowel disease and B cell autoimmune conditions.
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.