Longeveron granted FDA Type C Meeting ahead of ELPIS II data readout

Longeveron (LGVN) announced that the U.S. Food and Drug Administration has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout of ELPIS II, the pivotal Phase 2 clinical trial evaluating the Company’s proprietary stem cell therapy, laromestrocel, as a potential treatment for Hypoplastic Left Heart Syndrome, a rare pediatric and orphan-designated disease. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints and statistical analysis plan to support a Biologics Licensing Application. The Company expects to provide a regulatory update after the receipt of the official meeting minutes. ELPIS II is a Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy for HLHS. The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institutes of Health.