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.

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