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 (NASDAQ: MESO; ASX: MSB) generates frequent news flow as it advances and commercializes allogeneic cellular medicines for severe inflammatory diseases. Company announcements highlight developments around its mesenchymal lineage cell therapy platform, led by Ryoncil (remestemcel-L-rknd) for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD), as well as pipeline programs using remestemcel-L and rexlemestrocel-L.
News items commonly cover Ryoncil revenue trends, adoption across U.S. transplant centers, and reimbursement milestones such as assignment of a permanent HCPCS J-Code and expansion of coverage by commercial and government payers. Mesoblast also reports on trading updates, including quarterly activity reports that summarize revenue from cell therapy products and cash flow information released to the Australian Securities Exchange.
Investors following MESO news will see updates on clinical and regulatory progress, including pivotal trial plans for Ryoncil in adults with severe SR-aGvHD in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, and ongoing Phase 3 work with rexlemestrocel-L in chronic low back pain associated with degenerative disc disease. Company releases also discuss regulatory designations such as RMAT status for rexlemestrocel-L.
Corporate news includes financing arrangements like new credit facilities and convertible note programs, changes in board and executive roles, and participation in healthcare conferences. This news page aggregates Mesoblast’s press releases and related coverage so readers can review product performance, clinical milestones, capital structure updates, and governance developments in one place.
Mesoblast (Nasdaq:MESO) drew down US$75 million from a new five-year credit facility provided by director and shareholder Dr Gregory George and repaid its senior secured loan to Oaktree and part of a NovaQuest subordinated royalty facility on Dec 29, 2025.
Mesoblast may draw an additional US$50 million until June 30, 2026. The facility carries a fixed 8.00% annual rate, a five-year interest-only period, is initially unsecured until NovaQuest debt is repaid (no later than July 8, 2026), and thereafter will be secured solely by the Temcell royalty. Facility terms include no prepayment or exit fees, no encumbrance of material assets or IP, and 5-year warrants for ~323,000 ADS at US$21.51 per ADS subject to shareholder approval.
Mesoblast (Nasdaq:MESO) announced an independent peer‑reviewed meta‑analysis presented at the 67th ASH Annual Meeting showing remestemcel‑L had superior complete and overall remission versus ruxolitinib for steroid‑refractory acute graft versus host disease (SR‑aGvHD).
The meta‑analysis included 2,732 patients across 11 studies (644 received remestemcel‑L; 1,349 received ruxolitinib). Authors reported differences in hematology, cardiac, and hepatic adverse events and concluded both therapies improved quality of life but safety profiles differ. Ryoncil is noted as the first FDA‑approved mesenchymal stromal cell product and the only product approved for children under 12 with SR‑aGvHD.
Mesoblast (Nasdaq: MESO) will participate at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025. Silviu Itescu, Chief Executive, is scheduled for a fireside chat at 12:00 p.m. ET on Thursday, December 4, 2025. A live webcast will be available at the provided event link, and a replay will be posted for up to 30 days on Mesoblast’s investor events page.
Mesoblast (Nasdaq: MESO) issued a trading update at its Annual General Meeting, reporting expected Ryoncil gross revenue of more than US$30.0 million for the quarter ending Dec 31, 2025. The company said this represents a >37% increase versus US$21.9 million in Ryoncil gross revenue for the prior quarter ended Sep 30, 2025. The AGM address included a comprehensive operational overview alongside the trading update.
Mesoblast (Nasdaq: MESO) and the NIH-funded BMT CTN will launch a pivotal Phase 3 trial of Ryoncil (remestemcel-L-rknd) as part of a first-line regimen for adults with severe acute graft versus host disease refractory to corticosteroids (SR-aGvHD).
The randomized trial will compare ruxolitinib alone versus ruxolitinib plus Ryoncil, with the protocol to be submitted to FDA and enrollment targeted to begin in Q1 2026. Background data cited include 44–58% non-response to ruxolitinib at Day 28 in supportive studies and 20–30% 100-day survival after ruxolitinib failure; Mesoblast reported 76% Day-100 survival in its Expanded Access program for patients ≥12 who failed ruxolitinib or other second-line agents.
Mesoblast (Nasdaq: MESO) appointed James M. O’Brien as its US-based Chief Financial Officer effective Nov 17, 2025, to support the company’s transition to a fully integrated commercial organization.
O’Brien brings cross-functional finance leadership for commercialization of Ryoncil and potential label expansion, experience creating budgeting/forecasting and internal controls, and history managing transactions of nearly $10 billion. Prior roles include finance leadership at Actavis (proforma revenues >$8 billion), Nycomed ($750 million revenues), Cognition Therapeutics (oversaw IPO), Faron Pharmaceuticals, Bristol-Myers Squibb, and PwC; he is a certified public accountant.
Mesoblast (Nasdaq: MESO) said the FDA scheduled a meeting in early December to discuss data from its first Phase 3 trial (MSB-DR003) of rexlemestrocel-L in chronic low back pain (CLBP), including opioid reduction and cessation outcomes.
In the randomized 404-patient trial, 168 patients were on opioids at baseline and a single intra-discal injection of rexlemestrocel-L + HA produced >3-fold more patients who ceased all opioids by 36 months versus saline (p=0.008). Rexlemestrocel-L holds RMAT designation. Mesoblast is recruiting a 300-patient confirmatory Phase 3 across 40 US sites, with enrollment expected to complete in the coming quarter. The company is seeking FDA approval based on 12-month CLBP reduction data.
Mesoblast (Nasdaq: MESO) reported results for the quarter ended September 30, 2025. Cell therapy revenue totaled US$20.6M, up from US$12.9M the prior quarter. Ryoncil gross sales rose 66% to US$21.9M and net sales increased 69% to US$19.1M after a 12.7% gross-to-net adjustment.
The company held US$145M cash at quarter end and reported US$14.9M net operating cash spend. Mesoblast secured convertible note subscription agreements for up to US$50M (availability subject to shareholder approval). A permanent HCPCS J-code (J3402) for Ryoncil became active on Oct 1, 2025, federal Medicaid coverage is mandatory from July 1, 2025, and 40 transplant centers have been onboarded.
Mesoblast (Nasdaq: MESO) reported gross Ryoncil sales of US$21.9 million for the quarter ended September 30, 2025, a 66% increase versus the prior quarter ended June 30, 2025 with a similar gross-to-net adjustment.
Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell product and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD). Management cited payer reimbursement progress and noted adoption is expected to accelerate following a permanent CMS J-Code effective October 1, 2025.
Mesoblast (Nasdaq:MESO) announced that Medicare & Medicaid Services activated a permanent HCPCS J‑Code J3402 for Ryoncil (remestemcel‑L‑rknd) effective October 1, 2025. The J‑Code creates a standardized billing and reimbursement pathway for Ryoncil, intended to facilitate broader patient access and simplify payment for providers treating steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD) in children. The release notes Ryoncil is the first mesenchymal stromal cell product approved by the FDA and the only therapy approved for children under age 12 with SR‑aGvHD. Providers may submit claims using J3402 for dates of service on or after October 1, 2025, and are directed to ryoncil.com for coding guidance.