United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

March 25, 2024

https://www.globenewswire.com/news-release/2024/03/26/2852084/0/en/United-States-Food-Drug-Administration-FDA-Notifies-Mesoblast-that-Available-Clinical-Data-from-Phase-3-Trial-Appear-Sufficient-to-Support-BLA-Submission-for-Remestemcel-L-in-Child.html

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

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