Regenerative medicine, a rapidly advancing field, can be generally defined as a therapeutic methodology for the repair, ...
SR-aGVHD is not just another medical term—it’s a nightmare for families and patients alike. This severe condition strikes as a complication in children who receive life-saving allogeneic ...
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Mesoblast gains as FDA backs regulatory plans for cell therapyThe Australian biotech intends to seek regulatory approval for remestemcel-L as a treatment for children with steroid-refractory acute graft versus host disease (SR-aGVHD). SR-aGVHD is an immune ...
Approved in December 2024, Ryoncil is the first mesenchymal stromal cell or MSC therapy approved by the FDA for the treatment of steroid-refractory acute graft-versus-host disease or SR-aGvHD in ...
Mesoblast stock surged after FDA approval of Ryoncil for SR-aGVHD, but market size is limited with NPV of ~$1B vs $2.33B market cap. Ryoncil faces commercialization challenges: second-line therapy ...
Among a group of heavily pretreated aGvHD patients who were not responding to steroid therapies or had become dependent on them, MaaT013 was associated with an OS rate of 54% at six months ...
Mesoblast’s RYONCIL ® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal ...
Ryoncil ® was approved in December 2024 by the United States Food and Drug Administration (FDA) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months ...
Each year, approximately 375 pediatric patients in the U.S. are diagnosed with SR-aGvHD. The cost of treating a child who dies of SR-aGvHD within 12 months of transplant is approximately US$2.5 ...
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013.
Manufacturing: As a result of FDA approval of RYONCIL in December 2024, the US$23.0 million provision against the value of inventory manufactured and expensed in prior periods was reversed and is now ...
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