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Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy

 
• By Joseph Haas

Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.

FDA Complete response stamp holder
Mesoblast is planning new trial after second FDA complete response • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

For a second time, the US Food and Drug Administration has told Mesoblast Limited that a biologic licensing application for its cell therapy candidate for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) lacks necessary data. On a 4 August analyst call, Mesoblast said it now plans to conduct a small study in high-risk adult GVHD patients that it hopes will meet the agency’s requirements for approval.

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