Highlights

  • RYONCIL revenue expected to exceed USD 30M in Q2 FY26 based on ongoing demand.
  • Phase 3 programs for CLBP and adult aGvHD progress with key filings targeted for CY26.
  • Cash balance of USD 145M supports clinical, manufacturing and regulatory activities.

Mesoblast (ASX:MSB) continues to advance the commercial rollout of RYONCIL®, following its U.S. FDA approval in December 2024. As the first FDA-approved allogeneic MSC product, RYONCIL launched commercially in April 2025 and delivered gross revenue of USD 22M in Q1 FY26. The company expects Q2 FY26 gross revenue to exceed USD 30M, supported by ongoing demand in steroid-refractory acute graft-versus-host disease (SR-aGvHD).

More than 40 centers have been onboarded, with 45 of these centers accounting for approximately 80% of U.S. pediatric bone marrow transplants. Over 260M U.S. lives are covered under insurance, and a specific HCPCS J-Code has been assigned, alongside the establishment of a patient support hub.

Advancing Label Expansion Opportunities

Mesoblast is preparing to broaden RYONCIL’s label indications. A pivotal study in adults with severe SR-aGvHD, in collaboration with the NIH-funded BMT-CTN, is planned to commence in Q1 CY26. Adult patients who do not respond to second-line therapy have published survival rates of approximately 25% at Day 100, highlighting an area of unmet medical need.

An IND filing for a study in biologic-refractory inflammatory colitis is targeted for Q1 CY26, following engagement with key opinion leaders. This program is intended for both adult and pediatric populations.

Pipeline Progress Across Multiple Indications

The company continues development of rexlemestrocel-L across chronic inflammatory conditions. In chronic low back pain associated with degenerative disc disease, a confirmatory 300-patient Phase 3 trial across 40 U.S. sites is ongoing, with enrollment expected to complete in the coming quarter. Data readout and a potential BLA filing are anticipated in CY27.

Phase 3 data also indicated reduced opioid use among patients receiving rexlemestrocel-L combined with HA, with a subset eliminating opioid use by 36 months compared with saline controls. A meeting with the FDA is scheduled in December 2025 to discuss opioid-related findings from the prior randomized trial.

In chronic heart failure with reduced ejection fraction (HFrEF), Mesoblast remains aligned with the FDA on requirements for a BLA submission for accelerated approval in end-stage disease with LVADs.

Manufacturing and Financial Position

Manufacturing efforts are centered on expanding U.S. production capacity, diversifying facilities, increasing process yields, and reducing cost of goods. Commercial manufacturing for CHF and CLBP programs is planned to occur in the U.S.

As of 30 September 2025, Mesoblast reported a cash balance of USD 145M. The operating plan includes funding Phase 3 studies, manufacturing for regulatory filings, and commercial inventory, alongside future debt retirement or refinancing activities.

Share Price Snapshot

MSB was trading 1.50% higher at AUD 2.365 per share as of 25 November 2025.