Longeveron Inc. (NASDAQ: LGVN) announced updated results from its Phase 2b ELPIS II clinical trial on October 26, 2026. The trial evaluated laromestrocel, an investigational stem cell therapy, as an adjunct to Stage 2 palliative surgery for infants with hypoplastic left heart syndrome (HLHS).
The trial did not meet its primary efficacy endpoint of the change from baseline in right ventricular ejection fraction (RVEF) at Month 12. However, the company reported that the secondary endpoint of major adverse cardiac events (MACE) achieved statistical significance. The analysis showed eight MACE events in the standard of care arm compared to one event in the laromestrocel treatment arm, with a P-value of 0.043.
Among the 40 randomized infants in the intention-to-treat population, laromestrocel was associated with fewer adjudicated clinical and safety events. The treatment demonstrated a favorable safety and tolerability profile through 12 months, with no treatment-related serious adverse events identified.
Longeveron intends to request a meeting with the U.S. Food and Drug Administration (FDA) to review the results and determine potential next steps for the HLHS development program. The ELPIS II data have also been selected for a Late-Breaking Science Program podium presentation at the American Heart Association’s 2026 Scientific Sessions in Chicago on November 8, 2026.
