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Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease
Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s diseaseAlignment with FDA on proposed trial study design, population and endpointsInitiation of planned pivotal Phase 2/3 clinical trial anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering supportLaromestrocel (Lomecel-B™) has received FDA Re
About this update from Longeveron Inc.
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