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Longeveron's Phase 2b trial fails primary endpoint; explores strategic options
LGVNLongeveron Inc.
On September 16, 2026, Longeveron Inc. announced that its Phase 2b ELPIS II clinical trial for laromestrocel in infants with hypoplastic left heart syndrome (HLHS) failed to meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction at Month 12. The intent-to-treat analysis showed a least-squares mean difference of -0.7 percentage points between treatment groups, which was not statistically significant (p=0.8336). While exploratory endpoints indicated no deaths in the treated arm versus one in the control group over 12 months and approximately 31% fewer major adverse cardiovascular events, these findings were also not statistically significant. The company plans to analyze additional data and discuss potential next steps with the FDA. Concurrently, Longeveron initiated a process to explore all strategic options to maximize shareholder value, including engaging an investment bank as a strategic advisor and implementing cash conservation measures. Longeveron Inc. is a clinical-stage biotechnology company developing cellular therapies for rare pediatric and aging-related conditions.