Mesoblast (ASX:MSB) Reaches Multi-Year High as Ryoncil Revenue Targets US$30M: Is It Still a Buy?

Commercial momentum builds as Mesoblast targets two major 2026 catalysts: Adult label expansion and Revascor BLA filing.

Mesoblast (ASX: MSB) closed at A$2.91 last Friday, up 27% over the past month as investors position ahead of the company’s expected US$30 million-plus Q2 revenue report. The share price is now close to its January high of A$3.37. Investors who watched the company climb 48% over the past twelve months are asking a different question: whether this momentum points to more upside or if the market has already priced in the potential.

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Ryoncil Approval Makes Biotech History

Ryoncil treats steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older. That may sound technical, but here’s what matters: this is a devastating condition where transplanted cells attack a patient’s body, and until now, there was no approved treatment.

In Mesoblast’s Phase 3 trial, 70% of patients achieved an overall response by Day 28, significantly exceeding the 45% threshold set for approval. Patients who responded had an 87% survival rate at 100 days compared to just 47% for non-responders. Beyond the clinical success, the therapy is protected by seven years of orphan drug exclusivity and biologic rights through 2036, ensuring no rival MSC therapy can enter the market for a long time.

We believe this regulatory moat is one of Mesoblast’s strongest assets. The company’s position is further reinforced by the October 1, 2025, activation of its permanent HCPCS J‑Code (J3402), which gives a clear billing pathway under US Medicare and Medicaid. Together, these protections create a powerful barrier against competition, giving Mesoblast a strong edge in the years ahead.

The Commercial Challenge Ahead

While the approval was historic, the commercial reality is more nuanced. The target market for paediatric SR-aGvHD remains niche, with an addressable market of approximately 400 patients per year.

However, the revenue numbers are starting to tell a story of rapid adoption. Mesoblast reported net Ryoncil sales of US$19.1 million (gross US$21.9 million) in Q1 FY26. With the J-Code now active, the company has guided for gross revenues exceeding US$30 million for the quarter ending December 31, 2025. The company maintains a healthy cash position of approximately US$145 million, providing ample runway to reach its next clinical milestones.

The Investor’s Takeaway for Mesoblast

Mesoblast has successfully transitioned from a speculative R&D firm to a commercial leader. The bull case for 2026 is no longer just about paediatric success; it’s about the multi-billion-dollar scale-up.

The activation of the J‑Code (J3402) has removed the biggest hurdle for US hospital reimbursement, opening the door for Mesoblast to hit strong revenue targets. But the real upside lies in two major catalysts coming in 2026:

• Adult Label Expansion: A pivotal trial in adults, a market 3 to 4 times larger than the paediatric segment, is set to begin in Q1 2026.
• Revascor’s Path: With FDA alignment on an accelerated approval pathway for chronic heart failure, Mesoblast intends to file for accelerated approval for Revascor by year-end 2025.

Following its historic 2024 recovery, the stock now reflects its growing status as a platform play. For new investors, any pullback towards the A$2.80 support level could be a strategic entry point ahead of fresh clinical data and revenue updates in early 2026.