Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.
- Ryoncil gross sales rose 60% to US$35 million in Q2 FY2026
- New US$125 million non-dilutive credit facility at 8% fixed interest secured
- Early real-world data show 84% survival in pediatric SR-aGvHD patients treated with Ryoncil
- Pivotal adult SR-aGvHD trial expected to begin enrolment soon
- Positive FDA feedback on rexlemestrocel-L for chronic low back pain supports upcoming BLA filing
Strong Sales Momentum for Ryoncil
Mesoblast Limited (ASX – MSB) has delivered a robust performance for the quarter ended December 31, 2025, with Ryoncil gross sales soaring 60% to US$35 million compared to the previous quarter. Net revenues from Ryoncil reached US$30 million, reflecting growing market acceptance of the company’s pioneering mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children.
Ryoncil remains the only FDA-approved MSC therapy for children under 12 with this severe condition, and early real-world data from the first 25 treated patients post-launch are encouraging. Of these, 84% survived and completed the full 28-day treatment regimen, underscoring the therapy’s potential when administered promptly after steroid resistance is identified.
Financial Strength Bolstered by New Credit Facility
To underpin its growth and clinical ambitions, Mesoblast secured a new US$125 million non-dilutive credit facility at a fixed interest rate of 8% per annum, a significant improvement over its previous debt arrangements. The facility includes a five-year interest-only period and an initial unsecured tranche of US$75 million, with the remaining US$50 million available for drawdown until mid-2026.
This financial manoeuvre enhances Mesoblast’s flexibility to pursue strategic partnerships and advance label expansions for Ryoncil without diluting shareholder equity. The company ended the quarter with a strong cash position of US$130 million and anticipates reduced net cash outflows in the coming months due to steady revenue inflows and disciplined cost management.
Advancing Clinical Pipeline and Regulatory Engagements
Looking ahead, Mesoblast is preparing to initiate a pivotal trial for extending Ryoncil’s indication to adult patients with severe SR-aGvHD, a population roughly three times larger than the pediatric group. This trial is expected to commence enrolment imminently, potentially unlocking a substantial new market segment.
Meanwhile, the company received positive feedback from the FDA regarding its Biologics License Application (BLA) prospects for rexlemestrocel-L, an allogeneic cell therapy targeting chronic discogenic low back pain. The FDA acknowledged clinically meaningful pain reduction and opioid use decrease in Phase 3 trial data, supporting the potential for product approval. The confirmatory Phase 3 trial is actively recruiting patients across 40 US sites, with enrollment expected to complete shortly.
Manufacturing scale-up efforts for rexlemestrocel-L are progressing well, aimed at supporting BLA filings not only for chronic low back pain but also for end-stage chronic heart failure patients with left ventricular assist devices (LVADs). This dual indication strategy reflects Mesoblast’s broader ambition to leverage its proprietary cell therapy platforms across multiple inflammatory and degenerative conditions.
Intellectual Property and Market Position
Mesoblast maintains a formidable intellectual property portfolio with over 1,000 patents and applications protecting its mesenchymal stromal cell technologies through at least 2044 in key markets. This extensive IP coverage provides a strong moat as the company scales commercial operations globally, including established partnerships in Japan, Europe, and China.
With operations spanning Australia, the United States, and Singapore, Mesoblast is well positioned to capitalise on its innovative therapies and growing commercial footprint.
Bottom Line?
Mesoblast’s strong sales growth and improved financial footing set the stage for pivotal clinical milestones and potential market expansion in 2026.
Questions in the middle?
- How quickly will the adult SR-aGvHD pivotal trial enrol and what impact could it have on revenue?
- What are the timelines and likelihood for FDA approval of rexlemestrocel-L based on current Phase 3 data?
- How will Mesoblast leverage its new credit facility to accelerate partnerships or label expansions?