FDA gives thumbs down for Mesoblast's aGVHD drug, saying one single-arm trial is not enough
Mesoblast’s request for a trading halt Thursday turned out to be a negative.
Late Thursday evening, the Australian company announced that the FDA had issued a CRL for remestemcel-L, or Ryoncil, its pediatric acute graft-versus-host disease program. Mesoblast is planning to appeal the decision with a Type A meeting sometime in the next 30 days, and will seek a potential accelerated approval with a post-approval condition for an additional study.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.