Mesoblast receives complete response from u.s. food and drug administration for biologics license application for steroid-refractory acute graft versus host disease in children

New york, aug. 03, 2023 (globe newswire) -- mesoblast limited (nasdaq:meso; asx:msb), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the us food and drug administration (fda) has provided a complete response to its biologics license application (bla) resubmission for remestemcel-l for the treatment of pediatric steroid-refractory acute graft versus host disease (sr-agvhd) and requires more data to support marketing approval. to obtain the data required, mesoblast will conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. this adult study is in line with our overall commercial strategy, which envisioned a sequenced progression from pediatric to adult sr-agvhd indications. adults comprise 80% of the sr-agvhd market.
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