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Stock impact report

Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024

Mesoblast Limited - American Depositary Shares (MESO) 
US:NASDAQ Investor Relations: investorsmedia.mesoblast.com
Company Research Source: GlobeNewswire
NEW YORK, April 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2024. Mesoblast Chief Executive Silviu Itescu said: “We are very pleased with the positive interactions we had last quarter with the FDA, having received clarity on the path to licensure for our product candidates in pediatric acute graft versus host disease and in ischemic patients with chronic heart failure.” “Based on the clear responses and guidance from FDA we intend this quarter to resubmit our Biologics License Application (BLA) for approval of remestemcel-L in children with SR-aGVHD,” said Mesoblast CEO Dr. Silviu Itescu. “In addition, FDA informed us that the results from our pivotal study of rexlemestrocel-L in end-stage heart failure patients may support an accelerated approval, and we intend to have a pre-BLA meeting to discuss the data tha Show less Read more
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