Longeveron says secondary endpoint hit significance in ELPIS II after primary miss
Longeveron reported updated ELPIS II Phase 2b results for laromestrocel in 40 infants with hypoplastic left heart syndrome. The trial did not meet its primary endpoint of change in right ventricular ejection fraction at Month 12, but a pre-specified secondary endpoint, major adverse cardiac events (MACE), reached statistical significance. The company plans to request an FDA meeting, and the results are scheduled for presentation at the AHA 2026 Scientific Sessions.
Key points
- Primary endpoint not met: mean RVEF decreased 2.6 percentage points in the standard of care group and 3.3 points in the laromestrocel group, with no statistically significant difference (p=0.68).
- MACE: 8 events in the standard of care arm versus 1 in the laromestrocel arm (P=0.043).
- FDA previously advised Longeveron that RVEF alone would not be sufficient to demonstrate efficacy for regulatory approval.
- Data selected for a late-breaking podium presentation at AHA 2026 Scientific Sessions on November 8, 2026, in Chicago.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 26, 2026.
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