Longeveron's Failed ELPIS II Trial Delivers Significant MACE Benefit; FDA Meeting Planned

summarizeSummary

Longeveron reported updated ELPIS II data: the primary RVEF endpoint still missed, but the pre-specified MACE endpoint hit statistical significance (8 vs 1 event, P=0.043). The company will request an FDA meeting to discuss next steps for its HLHS program.

check_boxKey Events · Product Development and Regulatory · LGVN

• MACE Endpoint Reaches Significance

  On the pre-specified secondary endpoint of major adverse cardiac events, the standard-of-care arm recorded 8 events versus 1 in the laromestrocel arm (P=0.043).

• Primary RVEF Endpoint Still Missed

  Mean RVEF fell 2.6 points on standard of care and 3.3 points on laromestrocel, a baseline-adjusted difference of -1.36 (95% CI -8.0 to 6.7, p=0.68).

• FDA Meeting To Be Requested

  Management intends to request an FDA meeting to review the results and determine next steps for the HLHS development program; FDA has previously advised RVEF alone would not support approval.

• AHA Late-Breaker Presentation Set

  ELPIS II Phase 2 data will be presented in the late-breaking Featured Science session at the AHA 2026 Scientific Sessions on November 8, 2026 in Chicago.

auto_awesomeAnalysis · LGVN · Life Sciences

The primary RVEF endpoint still failed, but the pre-specified MACE analysis now shows 8 events on standard of care versus 1 on laromestrocel (P=0.043) — a hard clinical-outcome difference that the earlier disclosure did not quantify. That gives management something to take to the FDA, and the company says it will request a meeting to define next steps for the HLHS program. Against a going-concern warning and cash runway only into Q4 2026 (previously disclosed), this is the difference between a dead program and one with a possible path — but it is a secondary endpoint, and the FDA has already told the company RVEF alone would not support approval, so a regulatory path is not assured.