The Mesoblast Ltd (ASX: MSB) share price is currently up 27% after the ASX biotech share reported its quarterly update for the three months to June 2025.
It describes itself as the global leader of allogeneic cellular medicines for inflammatory diseases. Ryoncil is described as the first and only FDA-approved mesenchymal stromal cell (MSC) product in the US and became commercially available for purchase on 28 March 2025.
Let’s take a look at some of the highlights from the June quarter to see why the Mesoblast share price may be rising so strongly.
June quarter update
The company reported US$13.2 million of gross revenue from Ryoncil sales after the launch on 28 March to 30 June.
It also revealed US$1.6 million of revenue from royalties on sales of TEMCELL HS, sold in Japan by its licensee.
The company also reported US$16.6 million of net operating cash spend for the quarter. It had US$162 million of cash at 30 June 2025.
Ryoncil
Mesoblast has onboarded more than 25 transplant centres since the product launch and expecting to complete the onboarding process across all 45 priority transplant centres that account for approximately 80% of US pediatric transplants.
It also revealed that coverage Ryoncil continues to expand with over 250 million US lives insured by commercial and government payers. Federal Medicaid coverage for Centers for Medicare and Medicaid (CMS) is now in place. Mandatory fee-for-service Medicaid coverage for Ryoncil became effective on 1 July 2025 in all US states.
The company has also established a patient access hub called MyMesoblast where Ryoncil is available for ordering.
Also, during the quarter Ryoncil received seven years of orphan-drug exclusive approval from the US FDA for treatment of SR-aGvHD in pediatric patients aged two months and older. This means the FDA will not approve another MSC product during the next seven years.
On top of that, Mesoblast has biologic exclusivity, preventing another sponsor from referencing the Ryoncil biologic license application until December 2036, 12 years from its first approval which would prevent market entry by a ‘biosimilar’.
In July, Mesoblast held a Type B, meeting with FDA Ryoncil to discuss a pivotal trial in adults with SR-aGvHD. This trial will be conducted with the NIH-funded bone marrow transplant clinical trials network.
Revascor
Mesoblast also met with the FDA in June in follow-up to the successful Type B meeting in early 2024. The FDA stated the results of the presented studies with Revascor in the treatment of patients with ischemic heart failure with reduced ejection fraction and inflammation could support accelerated approval.
Overall, things are looking positive for the ASX biotech share, hence the big jump in the Mesoblast share price.
