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Investing.com -- Mesoblast Ltd (NASDAQ:MESO) stock surged 25% after the company reported its first quarter of sales for its newly approved drug Ryoncil, which generated $13.2 million in gross revenue.
The cellular medicines company launched Ryoncil on March 28, 2025, following FDA approval for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children. Ryoncil is the first and only FDA-approved mesenchymal stromal cell product in the United States.
In addition to product sales, Mesoblast reported $1.6 million in royalty revenue from its Japanese licensee for TEMCELL HS Inj. The company ended the quarter with a strong cash position of $162 million as of June 30.
The commercial rollout is progressing steadily, with more than 25 transplant centers onboarded since launch. Mesoblast expects to complete onboarding across all 45 priority transplant centers this quarter, which account for approximately 80% of U.S. pediatric transplants.
Insurance coverage for Ryoncil continues to expand, now covering over 250 million U.S. lives through commercial and government payers. Notably, mandatory fee-for-service Medicaid coverage became effective July 1 in all U.S. states.
The company has established patient access programs through its MyMesoblast hub to ensure treatment accessibility. Ryoncil also received seven years of orphan-drug exclusivity from the FDA, providing market protection through 2032, in addition to biologic exclusivity preventing biosimilar entry until December 2036.
Mesoblast is working to expand Ryoncil’s label to include adults with SR-aGvHD and continues development of its other pipeline products for chronic inflammatory heart failure and low back pain.
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