Longeveron announced updated ELPIS II results on October 26, 2026, reporting a statistically significant reduction in a prespecified secondary endpoint measuring major adverse cardiac events in infants receiving its investigational cell therapy, laromestrocel. The finding follows the Phase 2b trial’s failure to meet its primary endpoint of improving right ventricular ejection fraction at 12 months.
Key Takeaways
- The updated secondary analysis recorded eight major adverse cardiac events with standard care versus one with laromestrocel, with P=0.043.
- The secondary finding does not change the trial’s failure to meet its primary measure of heart function.
- Longeveron intends to request an FDA meeting; the data are scheduled for presentation on November 8, 2026.
ELPIS II results add a secondary clinical finding
The trial evaluated laromestrocel alongside Stage II palliative surgery in 40 infants with hypoplastic left heart syndrome, a rare congenital condition involving an underdeveloped left ventricle. Longeveron’s September topline announcement disclosed the primary endpoint failure and plans for further analysis.
The October update reported eight major adverse cardiac events, or MACE, in the standard-of-care arm versus one in the laromestrocel arm. The company described the result as statistically significant, with P=0.043, and said laromestrocel was associated with fewer adjudicated clinical and safety events.
Longeveron believes the secondary findings suggest potential to improve clinical outcomes. That remains a development-stage assessment, not an established treatment benefit or regulatory approval.
| Item | Details |
|---|---|
| Trial design | Phase 2b, randomized, double-blind, multicenter, two-arm study |
| Treatment administration | Single injection into heart muscle during Stage II surgery |
| Long-term follow-up | Transplant-free survival follow-up planned for up to five years |
Primary endpoint and analysis limits remain important
Baseline and 12-month cardiac magnetic resonance measurements were available for 28 of the 40 randomized infants: 15 receiving standard care and 13 receiving laromestrocel. Mean right ventricular ejection fraction declined by 2.6 percentage points and 3.3 percentage points, respectively, with no statistically significant difference between groups.
The September announcement described an exploratory, as-treated MACE analysis that was not statistically significant. The October update identifies its finding as a prespecified secondary endpoint; the two announcements should not be treated as a simple like-for-like change in event counts.
Longeveron reported no treatment-related serious adverse events through 12 months. The safety finding and secondary outcome provide additional information, but neither reverses the primary endpoint result.
FDA discussion and scientific presentation are next
Longeveron intends to request a meeting with the U.S. Food and Drug Administration to review the results and determine potential next steps for the HLHS program. No meeting date or agreed regulatory path was announced.
The company said the ELPIS II data were selected for a Late-Breaking Science Program podium presentation at the American Heart Association’s 2026 Scientific Sessions in Chicago. The presentation is scheduled for November 8, during the November 6–9 meeting.
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