United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

March 10, 2024

https://www.globenewswire.com/news-release/2024/03/10/2843446/0/en/United-States-Food-Drug-Administration-FDA-Supports-Accelerated-Approval-Pathway-for-Rexlemestrocel-L-in-End-Stage-Heart-Failure-Patients-with-a-Left-Ventricular-Assist-Device-LVAD.html

NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.

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