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) appointed Dr. Teresa Montagut as Head of Clinical Development and Medical Affairs, effective March 11, 2026. She will report to the Chief Medical Officer and lead medical affairs, investigator-initiated trials, clinical collaborations, and communications to advance cell therapy programs.
Dr. Montagut joins from Regeneron with prior roles at Novartis, Genentech, and Atara; she will support expansion of the FDA-approved product Ryoncil into pediatric and adult inflammatory indications.
Mesoblast (Nasdaq:MSO / MESO) reported H1 FY2026 results showing a commercial inflection driven by the U.S. launch of Ryoncil. Total revenue was US$51.3 million (gross sales US$57.0M; revenue after adjustments US$48.7M). Reported net loss improved to US$40.2 million with period-end cash of US$130.0 million and a US$125.0 million five-year credit facility. Operationally, 49 transplant centers are onboarded (target 64), CMS issued a specific HCPCS J-Code effective Oct 1, 2025, and lifecycle and second‑generation programs (rexlemestrocel-L) are advancing toward pivotal filings and BLAs. FY2026 Ryoncil net revenue guidance: US$110–120 million.
Mesoblast (Nasdaq:MESO) will host a webcast to discuss operational highlights and financial results for the half year ended December 31, 2025. The live webcast begins at 5:00 PM EST on Thursday, February 26, 2026 (9:00 AM AEDT, Friday, February 27, 2026).
According to the company, the webcast is accessible at the provided OpenBriefing link and an archived replay will be posted on Mesoblast's Investor page.
Mesoblast (Nasdaq: MESO) reported February 2026 EIND program data showing high survival with Ryoncil (remestemcel-L-rknd) in steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD) across children and adults and when used as second or third line.
Of 53 EIND patients treated ≥third line (89% grade III/IV), 15% died before completing treatment versus 2% in second‑line Phase 3 MSB‑GVHD001, underscoring earlier use after steroid resistance. A pivotal adult second‑line trial is expected to begin enrollment this quarter pending central IRB approval, aiming to support an adult label extension.
Mesoblast (Nasdaq: MESO) reported Ryoncil® gross sales of US$35M (a 60% QoQ increase) and net revenues US$30M for the quarter ended Dec 31, 2025. The company secured a US$125M non-dilutive credit facility (initial US$75M drawn), held US$130M cash, and had net operating cash spend of US$16M for the quarter.
Clinical updates: 21 of 25 early real-world Ryoncil patients (84%) completed 28-day treatment; pivotal adult SR-aGvHD trial to begin site enrollment; FDA gave positive feedback on a BLA pathway for rexlemestrocel-L in CLBP and MSB-DR004 is recruiting to 300 patients.
Mesoblast (Nasdaq:MESO) reported real-world pediatric outcomes for Ryoncil (remestemcel-L-rknd) since commercial launch in March 2025. Of the first 25 children treated post-launch, 21 (84%) completed the FDA-label 28-day regimen and were alive; four patients who did not complete treatment died within 28 days. Mesoblast has onboarded 45 transplant centers toward a 64-center target covering 94% of U.S. transplants, and reports payer coverage for over 260 million U.S. lives. A CMS HCPCS J-Code issued Oct 1, 2025 increased CMS usage in the last quarter. A pivotal adult trial with BMT-CTN is expected to begin site enrollment this quarter to seek FDA label expansion.
Mesoblast (NASDAQ:MESO) reported FDA feedback after a Type B meeting on a potential BLA for rexlemestrocel-L in chronic discogenic low back pain (CLBP). FDA acknowledged that pain-intensity results from the MSB-DR003 Phase 3 trial favor rexlemestrocel-L versus placebo and confirmed a clinically meaningful 12-month pain reduction can support product efficacy. FDA also said robust opioid-reduction results from at least one adequate and well-controlled trial could be included in product labeling. A second Phase 3 study, MSB-DR004, is >50% enrolled across 40 U.S. sites and aims for a 300-patient enrollment target within about three months. Rexlemestrocel-L holds RMAT designation for CLBP.
Mesoblast (Nasdaq:MESO) reported Ryoncil sales of US$35.1 million for the quarter ended December 31, 2025, a 60% increase versus the prior quarter. The company said Ryoncil is the first FDA-approved MSC product and will be evaluated in a pivotal adult second-line SR-aGvHD trial, targeting a market roughly three times larger than the pediatric market. Mesoblast also entered a US$125 million five-year interest-only facility with its largest shareholder that lowered its cost of capital, allowed repayment in full of its prior senior secured loan, and enabled partial repayment of a subordinated royalty facility, which the company expects to be fully repaid by mid-CY2026. The facility reportedly has no exit fees, no encumbrance of material assets or IP, and permits additional unsecured debt and licensing.
Mesoblast (Nasdaq: MESO) announced board leadership changes effective Jan 1, 2026 as the company shifts from development to revenue-generating commercialization.
Key points: Jane Bell will retire as Chair and remain on the board as a non-executive director; Philip Facchina is unanimously appointed non-executive Chair; Lyn Cobley is appointed Chair of the Audit and Risk Committee; William Burns remains Vice-Chair and Chair of Nomination and Remuneration. The board said the changes follow a periodic composition review and the company plans to strengthen U.S. commercial expertise over the next twelve months.
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.