Longeveron Inc. filed a current report on October 26, 2026, disclosing updated results from its ELPIS II Phase 2b clinical trial evaluating laromestrocel in infants with hypoplastic left heart syndrome.

Key Highlights

  • Trial did not meet primary endpoint: According to the filing, ELPIS II did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12.
  • MACE secondary endpoint reached statistical significance: The filing reported eight major adverse cardiac events (MACE) in the standard of care arm versus one in the laromestrocel arm (P=0.043).
  • Trial scope: The filing described ELPIS II as a Phase 2b study evaluating laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS).
  • NIH-funded investigators involved: The updated analysis was conducted by the company and National Institutes of Health (NIH) funded trial investigators, according to the filing.
  • FDA meeting planned: The company disclosed it "intends to request a meeting with the U.S. Food and Drug Administration (FDA) to review the results to determine potential next steps for the Company's HLHS development program."
  • Secondary endpoints favored laromestrocel: The filing stated that laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care arm.

Longeveron Reports Updated ELPIS II Results for Laromestrocel in Pediatric HLHS

Longeveron Inc. (NASDAQ:LGVN), a clinical-stage biotechnology company, disclosed updated clinical trial results via an 8-K filed on October 26, 2026. The data covers its ELPIS II Phase 2b trial, which evaluated laromestrocel, an investigational stem cell therapy, as an adjunct to Stage 2 palliative surgery in 40 infants diagnosed with hypoplastic left heart syndrome (HLHS). The updated findings followed planned additional analysis conducted jointly by the company and NIH-funded trial investigators.

According to the filing, the trial did not meet its primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12. However, the company disclosed that a pre-specified secondary endpoint analysis of major adverse cardiac events (MACE) reached statistical significance: eight MACE events occurred in the standard of care arm compared to one in the laromestrocel treatment arm, with a reported P-value of 0.043. The filing also noted that, based on secondary endpoints more broadly, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care arm.

The company characterized these findings in its own words, stating it "believes the favorable pre-specified secondary endpoint findings suggest that laromestrocel has the potential to meaningfully improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation." The company indicated it intends to request a meeting with the FDA to review the results and assess potential next steps. The filing includes cautionary language noting that forward-looking statements are subject to risks and uncertainties described in the company's Annual Report on Form 10-K for the year ended December 31, 2025, filed March 17, 2026, and other regulatory filings.

What Was Disclosed

Longeveron disclosed updated ELPIS II Phase 2b trial results showing the primary RVEF endpoint was not met, while a pre-specified secondary MACE endpoint reached statistical significance (P=0.043) favoring laromestrocel over standard of care in 40 HLHS infants. An FDA meeting request is planned.