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01.07.26 - 02:42
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Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs (GlobeNewswire EN)
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NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). Rexlemestrocel-L has received Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and has Regenerative Medicine Advanced Therapy (RMAT) designation for this patient population, providing eligibility for rolling and priority reviews of the BLA....
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29.04.26 - 02:57
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Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain (GlobeNewswire EN)
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NEW YORK, April 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its pivotal Phase 3 clinical trial evaluating rexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated with degenerative disc disease has achieved its patient recruitment target. This marks a significant milestone in Mesoblast's plans for commercialization of rexlemestrocel-L, its proprietary allogeneic stromal cell therapy targeting inflammatory processes underlying disc degeneration....
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15.04.26 - 02:12
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Mesoblast Acquires Chimeric Antigen Receptor (CAR) Platform Technology for Precision-Enhanced Cell Products (GlobeNewswire EN)
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NEW YORK, April 14, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has acquired an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic mesenchymal lineage stromal cell (MSC) products. Mesoblast plans to incorporate the engineered CARs to further boost effectiveness of Mesoblast's products, with the goal of enhancing the target specificity and augmenting inherent properties of immunomodulation and tissue regeneration....
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