Mesoblast Stock Price, News & Analysis

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.

Mesoblast (NASDAQ:MESO) has confirmed that its cell therapy products, including FDA-approved Ryoncil®, are manufactured in the United States from U.S. donors and designated as U.S. origin products. This designation means they are exempt from tariffs on imported branded or patented pharmaceutical products.

Ryoncil® stands as the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically approved for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older. The company maintains U.S.-based manufacturing for all its products, including treatments for chronic heart failure, chronic back pain, and other inflammatory conditions.

Mesoblast (NASDAQ:MESO) presented at the Morgan Stanley and Cantor Fitzgerald Annual Global Healthcare Conferences, highlighting the successful commercial launch of Ryoncil®, their FDA-approved mesenchymal stromal cell (MSC) product.

CEO Silviu Itescu discussed the strong first quarter launch and product sales for treating children with steroid-refractory acute graft versus host disease (SR-aGvHD). The company plans to expand Ryoncil®'s indications to include adult SR-aGvHD and inflammatory bowel disease (IBD), while advancing Phase 3 milestones for their second-generation product Rexlemestrocel-L.

Mesoblast (NASDAQ:MESO) has secured an option to issue up to US$50 million in convertible notes through agreements with SurgCenter principals and existing shareholders. The 5-year convertible notes, available in US$10 million tranches, feature a 5% annual coupon and can be converted to shares at US$16.25 per ADR, representing a 126% premium to Nasdaq's closing price.

The funding, subject to shareholder approval at the upcoming AGM, will be used to repay secured lenders and support working capital needs. As part of the agreement, investors will receive a US$100,000 commitment fee and warrants for up to 5 million ordinary shares, with 2 million granted upon agreement and 3 million if Mesoblast exercises the option.