Mesoblast Limited MESO announced new analyses from the landmark DREAM-HF Phase 3 trial of rexlemestrocel-L in HFrEF patients with diabetes and/or ischemia who are at high risk of cardiovascular mortality, heart attacks, or strokes.
- In recent guidance to Mesoblast, FDA confirmed that reduction in the incidence of cardiovascular mortality or irreversible morbidity is a clinically meaningful acceptable endpoint and encouraged Mesoblast to identify the highest-risk group with the greatest likelihood of beneficial response.
- Mesoblast performed additional analyses of MACE outcomes in pre-specified high-risk patient groups.
- A single rexlemestrocel-L dose on top of maximal standard of care therapies reduced the composite 3-point MACE in all 537 patients by 33% over a mean follow-up of 30 months.
- A hierarchical analysis across pre-specified high-risk subgroups showed the most significant benefit in diabetes and/or myocardial ischemia patients.
- Rexlemestrocel-L, added to optimal standard of care therapies, reduced the 3-point MACE composite of cardiovascular death or heart attack or stroke by 37% across all HFrEF patients with diabetes and/or ischemia and by 54% in HFrEF patients with systemic inflammation.
- Related Link: Mesoblast's Remestemcel Shows Promising Action In Patients With Heart Failure
- Price Action: MESO shares closed 5.57% higher at $5.50 on Friday.
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