Mesoblast to File BLA for Ryoncil® FDA Approval Next Week

NEW YORK, July 01, 2024 – Mesoblast Limited (Nasdaq: MESO; ASX: MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced its plan to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) next week. The application seeks approval for Ryoncil® (remestemcel-L) for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast is at the forefront in developing off-the-shelf cellular therapies designed to combat severe and life-threatening inflammatory conditions. The company employs its proprietary mesenchymal lineage cell therapy technology to create a diverse portfolio of late-stage product candidates. These therapies work by releasing anti-inflammatory agents that modulate various components of the immune system, helping significantly reduce damaging inflammation.

The company boasts an extensive global intellectual property portfolio, ensuring protection through at least 2041 in major markets. Mesoblast’s proprietary manufacturing techniques provide industrial-scale, cryopreserved, off-the-shelf cellular medications. These therapies are intended to meet strict pharmaceutical release criteria and are planned to be readily accessible to patients worldwide.

Mesoblast’s product development focuses on two main technology platforms: remestemcel-L and rexlemestrocel-L. Remestemcel-L is aimed at treating inflammatory diseases in both children and adults, including conditions such as steroid-refractory acute graft versus host disease and biologic-resistant inflammatory bowel disease. Meanwhile, rexlemestrocel-L is being developed to address advanced chronic heart failure and chronic low back pain. The company has already commercialized two products in Japan and Europe through its licensees and has established commercial partnerships in Europe and China for certain Phase 3 assets.

Headquartered in three key locations—Australia, the United States, and Singapore—Mesoblast is listed on the Australian Securities Exchange (MSB) and Nasdaq (MESO).