Mesoblast Stock Price, News & Analysis

Mesoblast (NASDAQ:MESO) has confirmed that its cell therapy products, including FDA-approved Ryoncil®, are manufactured in the United States from U.S. donors and designated as U.S. origin products. This designation means they are exempt from tariffs on imported branded or patented pharmaceutical products.

Ryoncil® stands as the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically approved for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older. The company maintains U.S.-based manufacturing for all its products, including treatments for chronic heart failure, chronic back pain, and other inflammatory conditions.

Mesoblast (NASDAQ:MESO) presented at the Morgan Stanley and Cantor Fitzgerald Annual Global Healthcare Conferences, highlighting the successful commercial launch of Ryoncil®, their FDA-approved mesenchymal stromal cell (MSC) product.

CEO Silviu Itescu discussed the strong first quarter launch and product sales for treating children with steroid-refractory acute graft versus host disease (SR-aGvHD). The company plans to expand Ryoncil®'s indications to include adult SR-aGvHD and inflammatory bowel disease (IBD), while advancing Phase 3 milestones for their second-generation product Rexlemestrocel-L.

Mesoblast (NASDAQ:MESO) has secured an option to issue up to US$50 million in convertible notes through agreements with SurgCenter principals and existing shareholders. The 5-year convertible notes, available in US$10 million tranches, feature a 5% annual coupon and can be converted to shares at US$16.25 per ADR, representing a 126% premium to Nasdaq's closing price.

The funding, subject to shareholder approval at the upcoming AGM, will be used to repay secured lenders and support working capital needs. As part of the agreement, investors will receive a US$100,000 commitment fee and warrants for up to 5 million ordinary shares, with 2 million granted upon agreement and 3 million if Mesoblast exercises the option.

Mesoblast (NASDAQ:MESO) reported significant achievements for FY2025, highlighted by the FDA approval and successful launch of Ryoncil®, the first FDA-approved MSC therapy in the US for steroid-refractory acute graft-versus-host disease in pediatric patients. The company reported product revenue of $17.2 million, up 191% year-over-year, with Ryoncil® contributing $11.3 million in net sales in its first quarter of launch.

Financial position remains strong with $162 million cash on hand. The company expanded market coverage to over 250 million US lives and onboarded 32 transplant centers. Net loss for FY2025 was $102.1 million, compared to $88.0 million in FY2024. The company is pursuing label extensions for Ryoncil® in adults with SR-aGvHD and inflammatory bowel disease, while advancing its pipeline including Revascor® for heart failure and Rexlemestrocel-L for chronic low back pain.

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.