Mesoblast Stock Price, News & Analysis

Mesoblast (NASDAQ:MESO), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced a webcast to discuss their full-year financial results and operational highlights for the period ending June 30, 2025.

The webcast is scheduled for Thursday, August 28 at 6:30 PM EDT (Friday, August 29, 8:30 AM AEST). Investors can access the webcast through the company's provided link, and a recording will be available on Mesoblast's investor relations webpage.

Mesoblast (NASDAQ:MESO) reported strong initial results from the commercial launch of Ryoncil®, its FDA-approved mesenchymal stromal cell product for steroid-refractory acute graft-versus-host disease in children. The company achieved $13.2 million in gross revenue from Ryoncil® sales in its first quarter post-launch (March 28 - June 30, 2025).

Key operational highlights include: onboarding of 25+ transplant centers, coverage expansion to over 250 million US lives, and implementation of mandatory state CMS coverage effective July 1. The company maintains a strong cash position of $162 million and secured seven years of orphan-drug exclusivity plus biologic exclusivity through 2036.

Additionally, Mesoblast is advancing its pipeline with ongoing developments in chronic heart failure and chronic low back pain treatments.

Mesoblast (NASDAQ:MESO) has announced a significant regulatory advancement for its Revascor® (rexlemestrocel-L) treatment. The company has achieved alignment with the FDA on key requirements for filing a Biologics License Application (BLA) for treating patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.

Following a successful Type B meeting under the existing Regenerative Medicine Advanced Therapy (RMAT) designation, where the FDA indicated that presented studies could support accelerated approval, Mesoblast met with the FDA on June 3, 2025. The FDA's formal minutes confirmed alignment on critical aspects including chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and the proposed design and primary endpoint for the post-approval confirmatory trial.

The company plans to file for accelerated approval by the end of 2025, specifically targeting patients with end-stage ischemic HFrEF who have been implanted with a left ventricular assist device (LVAD).

Mesoblast (MESO) reports positive progress with FDA regarding two key products: Revascor® for heart failure and Ryoncil® for GvHD. The company held a Type B meeting with FDA under RMAT designation for Revascor®, achieving alignment on CMC, potency assays, and confirmatory trial design. For Ryoncil®, already FDA-approved for children with SR-aGvHD, Mesoblast plans to discuss a pivotal trial for adult treatment extension. Since its March 2025 launch, Ryoncil® has exceeded expectations with over 20 transplant centers onboarded and insurance coverage reaching 220 million US lives. By July 2025, all 51 States will provide Medicaid coverage, impacting 24 million lives. The commercial launch has shown strong physician adoption and hospital onboarding in the first ten weeks.

Mesoblast (MESO) has secured a significant regulatory milestone as the FDA granted seven years of orphan-drug exclusive approval for Ryoncil® (remestemcel-L), their treatment for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The exclusivity prevents FDA approval of competing mesenchymal stromal or stem cell products for this indication until 2032.

Additionally, the company's biologic exclusivity extends until December 2036, preventing biosimilar competition. Mesoblast's intellectual property protection for SR-aGvHD treatments extends through 2044, creating a robust commercial barrier against competitors.

Mesoblast reported key developments for Q3 2025, highlighted by the successful US commercial launch of Ryoncil®, the first FDA-approved mesenchymal stromal cell therapy for acute GVHD in children. The company ended the quarter with a strong cash position of US$182 million.

Key operational highlights include:

• 15 Ryoncil® infusion kits sold since March 28 launch
• Coverage expanded to over 104 million US lives
• Ten priority transplant centers onboarded with MyMesoblast™ hub
• Nine key account managers deployed to accelerate center onboarding

The company is advancing other programs including Revascor® for chronic heart failure and rexlemestrocel-L for chronic low back pain. A global private placement raised A$260 million, strengthening their financial position. Mesoblast joined the S&P/ASX 200 Index in March 2025.

Mesoblast, a global leader in allogeneic cellular medicines, has appointed Lyn Cobley to its Board of Directors. Cobley brings over 30 years of financial services experience, having served as CEO of Westpac Institutional Bank and Group Treasurer of Commonwealth Bank of Australia.

The appointment follows Mesoblast's recent FDA approval of Ryoncil®. Cobley currently serves as a director of Commonwealth Bank of Australia and holds positions at Macquarie University Council and EXL APAC Advisory Council.

As an Independent Non-Executive Director, Cobley will contribute to Mesoblast's growth during key milestones, including commercialization expansion and development of treatments for highly prevalent diseases. Board Chair Jane Bell highlighted Cobley's extensive corporate finance and governance experience in regulated industries as valuable assets for the company's future.

Mesoblast (MESO) has expanded insurance coverage for its FDA-approved therapy Ryoncil® (remestemcel-L) to reach over 104 million US lives. The coverage includes both government and commercial payers.

The therapy, which is the first mesenchymal stromal cell (MSC) treatment approved by the FDA, has achieved significant coverage milestones:

• 37 out of 51 states now provide fee-for-service Medicaid coverage through Orphan Drug Lists or medical exception/prior authorization process, covering 20 million lives (80% of total Medicaid fee-for-service lives)
• Remaining states will implement mandatory coverage for 24 million lives by July 1, 2025
• Commercial plans and managed Medicaid have established policies covering 84 million lives

Additional coverage through Medical Exceptions policies exists but is not included in these figures, suggesting the total coverage is higher than reported.

Mesoblast (Nasdaq:MESO) announced that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to U.S. tariffs as they are designated as 'U.S. Country of Origin' products. The company's products are manufactured from U.S. donors within the United States.

Ryoncil® holds the distinction of being the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication. It is specifically approved for treating pediatric patients 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD), a high-mortality condition.