The Mesoblast Ltd (ASX: MSB) share price has moved 10.6% higher in June and is trading at $1.88, up 1.18%, at the time of writing.
In earlier trading, Mesoblast shares reached an intraday peak of $1.94, which is a 10-week high.
There is no price-sensitive news from the ASX biotech company today.
Investors have watched the Mesoblast share price gradually disintegrate in 2025 after a big surge late last year.
The 11% gain this month is encouraging, but it's too early to determine if an upward trend is emerging.
The Mesoblast share price has been rangebound between about $1.50 and the early $1.90 mark since early April.
Let's recap the year-to-date performance.
Mesoblast share price 11% higher so far this month
In December 2024, the market bubbled over with excitement after Meosblast finally secured approval for its flagship drug in the US.
That drug was remestemcel-L, or Ryoncil, which treats steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children.
The Mesoblast share price ripped by almost 70% between 19 December and 2 January after the company announced the approval.
Mesoblast shares hit a four-year high of $3.37 per share on 2 January.
As the chart below shows, the Mesoblast share price has since been on a steady decline as the market's exuberance waned.
What's the latest news on Ryoncil?
The last lot of news on Ryoncil came on 15 May, which was also the most recent price-sensitive announcement out of Mesoblast.
Mesoblast advised investors that the US FDA had provided seven years of orphan-drug exclusive approval.
An orphan drug is a medication or treatment developed specifically to treat a rare disease or condition.
A rare disease or condition is defined as affecting fewer than 200,000 people nationwide in the US.
Mesoblast said the period of statutory exclusivity meant the FDA would not approve another mesenchymal stromal or stem cell (MSC) product for SR-aGvHD for at least seven years.
Mesoblast added:
Separately, Mesoblast has biologic exclusivity preventing another sponsor from referencing the Ryoncil biologic license application (BLA) until December 2036, twelve years from its first approval which would prevent market entry by a biosimilar.
Ryoncil was made commercially available to US clinics in late March.
To date, 37 of the 51 US states are providing fee-for-service Medicaid coverage for Ryoncil. The others will do so by 1 July.
By the end of this month, Mesoblast estimates more than 20 transplant centres will have been onboarded, which is more than expected.
On 12 June, Mesoblast released an update on its efforts to extend Ryoncil to adults.
Mesoblast has secured a meeting with the FDA in early July to discuss an adult trial.
The trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN).
What's next for Mesoblast?
Mesoblast also told investors it had met with the FDA in early June to discuss an accelerated approval pathway for its new drug, Revascor.
Revascor (rexlemestrocel-L) is a treatment for patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.
The biotech is getting ready to seek approval for Revascor.
The meeting focused on what would be required in a formal Biologics License Application (BLA).
Mesoblast said:
There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.
The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing.
Mesoblast CEO Dr Silviu Itescu said:
We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs.
We are also encouraged by the strength of the Ryoncil commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch.
Itescu said Meosblast shares investors could expect an update on Ryoncil sales in the quarterly activities report at the end of July.
