Mesoblast

FDA approves Mesoblast's Ryoncil, the first mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in pediatric patients. The approval is based on a Phase III trial showing a 70% response rate. Ryoncil uses MSCs from bone marrow donors to modulate the immune response and reduce inflammation.

Mesoblast's Ryoncil (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy in the U.S., specifically for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children. Ryoncil modulates the immune system, inhibiting T-cell activation and reducing cytokine release, showing a 70% overall response rate in a Phase 3 trial. The approval positions Mesoblast in a $10bn global GvHD market, with plans to expand Ryoncil's use to adults.

Mesoblast's shares surged 39% after FDA approval of Ryoncil®, the first mesenchymal stromal cell therapy in the U.S., for steroid-refractory acute graft versus host disease in children. A Phase 3 trial showed 70% response rate by Day 28, significant for survival prediction. Ryoncil will be available at U.S. transplant centers, offering a new treatment for about 1,500 children annually.

The FDA approved Ryoncil, the first mesenchymal stromal cell therapy, for treating steroid-refractory acute graft-versus-host disease in pediatric patients. Ryoncil, derived from donor bone marrow, demonstrated effectiveness in a study with 54 pediatric participants, showing complete or partial responses. The FDA emphasized its commitment to innovative therapies for life-threatening conditions.

Remestemcel-L-rknd (Ryoncil; Mesoblast) received FDA approval for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients, marking the first mesenchymal stromal cell therapy in the U.S.

The FDA approved remestemcel-L (Ryoncil), the first mesenchymal stromal cell therapy for pediatric patients with steroid-refractory acute graft-versus-host disease. The approval is based on a phase III trial showing 30% complete response and 41% partial response at day 28. Remestemcel-L, derived from MSCs, aims to reduce systemic inflammation.

Mesoblast's Ryoncil, a mesenchymal stromal cell therapy, gains FDA approval for treating steroid-refractory acute graft versus host disease in pediatric patients. It's the only MSC therapy approved in the US for any indication, with further development for adult SR-aGvHD and biologic-resistant inflammatory bowel disease. Other therapies under development include treatments for chronic lower back pain and heart failure, with commercial partnerships in China, Japan, and Europe.

Ryoncil (remestemcel-L-rknd), developed by Mesoblast, is the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host-disease (SR-aGVHD) in pediatric patients. The approval is based on a phase 3 trial showing 30% complete response and 41% partial response in 54 pediatric patients. Ryoncil's immunomodulatory effects suggest potential for treating other inflammatory conditions.

Mesoblast's shares surged after FDA approved Ryoncil, the first mesenchymal stromal cell therapy in the US, for children with steroid-refractory acute graft versus host disease (SR-aGvHD). Ryoncil showed a 70% overall response rate in a phase three trial. Mesoblast plans to raise up to US$50 million for the product launch.

Mesoblast CEO Silviu Itescu highlights the FDA approval of Ryoncil, the company's first commercial product in 20 years, marking a significant milestone for its pipeline of cell therapies for life-threatening diseases. Shares surged 54% following the approval.