Longeveron announces outcome of Type B meeting with FDA on Lomecel-B

Longeveron (LGVN) announced the outcome of a Type B meeting with the U.S. Food and Drug Administration, supporting the advancement of laromestrocel, a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzheimer’s disease. The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and frequency, trial duration and trial endpoints. To accelerate the pathway to potential approval, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study. Longeveron has previously completed two positive clinical trials studying patients with mild AD: a Phase 1 study and a multi-center, randomized, double-blind, placebo-controlled Phase 2a clinical trial, results of which were presented at the 2024 Alzheimer’s Association International Conference and published in Nature Medicine in March 2025. The Phase 2a CLEAR-MIND study results showed a favorable safety profile, absence of amyloid-related imaging abnormalities with laromestrocel administration, and several domains of potential clinical efficacy, including cognition, function, quality of life, and reduction in brain atrophy. The results of the CLEAR-MIND trial formed the basis for the FDA RMAT designation. Contingent upon obtaining additional non-dilutive funding and/or partnering support, the Company anticipates initiating the pivotal clinical trial in the second half of 2026.