Mesoblast Limited (MESO,MSB.AX) said that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast's allogeneic mesenchymal precursor cell or MPC product, in patients with end-stage ischemic heart failure with reduced ejection fraction or HFrEF and a left ventricular assist device or LVAD.
FDA provided the 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.
In feedback provided to Mesoblast regarding potential pathways to licensure for rexlemestrocel-L, FDA's comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval.
Mesoblast noted that it plans to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.