Longeveron

Longeveron

LGVN
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LGVN · Stock Price

USD 0.85-0.13 (-13.06%)
Market Cap: $25.0M

Historical price data

Market Cap: $25.0MPipeline: 10 drugsFounded: 2014Employees: 11-50HQ: Miami, United States

Overview

Longeveron Inc. is a Miami-based biotech focused on developing regenerative cellular therapies to improve healthspan by targeting chronic, aging-related diseases and life-threatening conditions. Its core achievement is the advancement of laromestrocel (Lomecel-B™), an allogeneic MSC therapy, into late-stage trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, supported by key regulatory designations like RMAT and Fast Track. The company's strategy leverages a vertically integrated manufacturing platform and pursues high-unmet-need indications with a multi-modal therapeutic hypothesis, aiming for near-term pivotal data in 2026 to drive potential BLA submissions.

CardiologyNeurologyGeriatrics

Technology Platform

Platform based on culture-expanded, allogeneic Medicinal Signaling Cells (MSCs) sourced from young adult donor bone marrow, designed to exert multi-modal therapeutic effects through immunomodulation, paracrine signaling, angiogenesis, and tissue repair.

Pipeline

10
10 drugs in pipeline
DrugIndicationStageWatch
Allogeneic MSCMild Alzheimer's DiseasePhase 2
Longeveron Mesenchymal Stem Cells (LMSCs)Aging FrailtyPhase 2
Lomecel-B medicinal signaling cellsHypoplastic Left Heart SyndromePhase 2
Peripheral Intravenous (IV) infusion of LMSCsMetabolic DiseasePhase 2
Longeveron Mesenchymal Stem CellsHLHSPhase 1/2

Opportunities

Potential multi-billion dollar markets in Alzheimer's disease and Aging Frailty, coupled with a high-value orphan drug opportunity in HLHS with expedited regulatory pathways (RMAT, Fast Track, Orphan designation).
Positive ELPIS II data in 2026 could be a major value-inflection point.

Risk Factors

High binary risk on pivotal HLHS trial data in Q3 2026.
Limited financial runway necessitates dilutive capital raises.
Low market cap and stock volatility increase investment risk.
Commercialization challenges for a novel cell therapy in complex care settings.

Competitive Landscape

In HLHS, competes primarily against standard surgical care with a unique regenerative approach. In Alzheimer's, faces intense competition from large pharma's antibody therapies but offers a mechanistically distinct cell-based strategy targeting inflammation and repair.