Mesoblast Limited shared financial results for the period ending June 30, 2025, including record revenue of US$17.2 million and FDA approval for Ryoncil® in pediatric patients with SR-aGvHD. The company aims to expand indications for Ryoncil® and launch new platform technologies for heart failure and chronic low back pain.

Revenue growth was driven by successful launch of Ryoncil®, with US$13.2 million in gross sales and US$11.3 million in reported net sales. Operating cash spend was US$50.0 million, with US$162 million cash on hand. Mesoblast was added to S&P/ASX 200 Index and Nasdaq Biotechnology Index.

Mesoblast is dedicated to bringing innovative off-the-shelf cellular medicines to market for inflammatory diseases. Their product portfolio includes Ryoncil® and Revascor®, with potential market opportunities in IBD, heart failure, and chronic low back pain. The company boasts a competitive advantage with proven scientific approach and extensive IP.

Ryoncil® became the first FDA-approved MSC product in the US, available for patients aged 2 months and older. Mesoblast also plans to extend Ryoncil®’s label to adults with severe SR-aGvHD. The company has established a patient access hub, MyMesoblast™, to help patients and caregivers access Ryoncil®.

Mesoblast’s financial results for FY2025 show revenue growth of 191%, with total revenue of US$17.2 million. Loss after tax was US$102.1 million, with net loss per share of 8.46 US cents. The company’s strong balance sheet supports Ryoncil® launch and future pipeline expansion.

Mesoblast continues to drive innovation in cellular medicines, with upcoming milestones including Ryoncil® trials for label expansion and Revascor® BLA submission. The company’s commitment to developing additional cell therapies for various indications demonstrates their dedication to improving patient outcomes.

Read more at GlobeNewswire: Banner Year for Mesoblast With First FDA Product Approval